PsoriasisPhase 3NCT01186744
A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
A Phase 3 study testing CP-690,550 in people with Psoriasis, run by Pfizer at 87 sites in 12 countries.
Trial summary
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- CP-690,550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 87 sitesin 12 countries
- Study dates
- Sep 2010to Jan 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
- Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
- No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.
Who cannot join
- Non-plaque or drug induced forms of psoriasis;
- Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
- Any uncontrolled significant medical condition.
Trial locations and contacts
87 sites in 12 countries.
87 sites in 12 countries
United States50 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Northeast Dermatology Associates
Beverly, Massachusetts, 01915
Medical Research South, LLC
Charleston, South Carolina, 29407
Office of Marta T. Hampton, MD
Charleston, South Carolina, 29407
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29414
Jewish Hospital
Cincinnati, Ohio, 45236
Radiant Research, Inc.
Cincinnati, Ohio, 45249
Mountain State Clinical Research
Clarksburg, West Virginia, 26301
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Duke University Medical Center
Durham, North Carolina, 27710
Deaconess Clinic Downtown
Evansville, Indiana, 47713
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Associates In Research, Inc.
Fresno, California, 93720
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Office of John Michael Humeniuk, MD
Greer, South Carolina, 29650
Radiant Research, Inc.
Greer, South Carolina, 29651
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, 01830
Dermatology Consulting Services
High Point, North Carolina, 27262
Longmont Clinic, PC
Longmont, Colorado, 80501
Dermatology Research Associates
Los Angeles, California, 90045
Expresscare Medical
Los Angeles, California, 90045
DMIA
Louisville, Kentucky, 40207
DermResearch, PLLC
Louisville, Kentucky, 40217
Quest Diagnostics
Louisville, Kentucky, 40217
Florida Academic Dermatology Center
Miami, Florida, 33136
International Dermatology Research, Inc.
Miami, Florida, 33144
Horizon Research Group, Inc.
Mobile, Alabama, 36608
Dermatology Research Associates
Nashville, Tennessee, 37203
Dermatology Specialists, Inc.
Oceanside, California, 92056
Park Avenue Dermatology, PA
Orange Park, Florida, 32073
Ameriderm Research
Ormond Beach, Florida, 32174
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Rhode Island Hospital
Providence, Rhode Island, 02903
Office of Stephen Miller, MD, PA
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94118
Miami Research Associates
South Miami, Florida, 33143
Springfield Clinic, LLP
Springfield, Illinois, 62703
Springfield Clinic
Springfield, Illinois, 62703
New England Research Associates, LLC
Trumbull, Connecticut, 06611
Radiant Research, Inc.
Tucson, Arizona, 85710
Center for Clinical Studies
Webster, Texas, 77598
Dermatology Associates
Wilmington, North Carolina, 28401
New Hanover Medical Group, PA
Wilmington, North Carolina, 28401
New Hanover Medical Research
Wilmington, North Carolina, 28401
PMG Research of Wilmington LLC
Wilmington, North Carolina, 28401
Piedmont Imaging
Winston-Salem, North Carolina, 27103
Piedmont Medical Research
Winston-Salem, North Carolina, 27103
Triad Dermatology, PA
Winston-Salem, North Carolina, 27103
Canada8 sites
Dermatrials Research
Hamilton, Ontario, L8N 1V6
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, G1V 4X7
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, A1C 2H5
Derm Research @ 888 Inc.
Vancouver, British Columbia, V5Z 3Y1
UBC Department of Dermatology and Skin Science
Vancouver, British Columbia, V5Z 4E8
Windsor Clinical Research
Windsor, Ontario, N8W 5L7
Australia6 sites
Skin and Cancer Foundation
Carlton, Victoria, 3053
Uniradiology
Carlton, Victoria, 3053
Dr. Glenn & Partners
Kogarah, New South Wales, 2217
Premier Dermatology
Kogarah, New South Wales, 2217
Malvern Diagnostic Imaging
Malvern, Victoria, 3144
Emeritus Research
Malvern East, Victoria, 3145
Bulgaria5 sites
Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
Pleven, 5800
Tsentar za kozhno-venericheski zaboliavania� EOOD
Sofia, 1404
Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
Sofia, 1407
Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
Sofia, 1431
MBAL na Voennomeditsinska akademia- Sofia
Sofia, 1606
Argentina3 sites
Centro de Investigaciones Dermatologicas
Buenos Aires, C1114aap
Centro de Investigaciones Dermatologicas
Buenos Aires, C1114AAP
IMAI (Instituto Medico de Asistencia e Investigaciones)
Buenos Aires, C1425AWC
Denmark3 sites
Department of Dermatology, Aarhus University Hospital
Aarhus C, 8000
Gentofte Hospital
Hellerup, 2900
Hudklinikken
Svendborg, 5700
Greece3 sites
Dermatology Department, Andreas Sygros Hospital
Aathens, 16121
University Hospital of Ioannina/Dermatology Department
Ioannina, 45500
"Papageorgiou" General Hospital / B' Dermatology and Venereology Clinic of University of Thessalonik
Thessaloniki, 56403
United Kingdom3 sites
Whipps Cross University Hospital, Department of Dermatology
London, Leytonstone, E11 1NR
Salford Royal NHS Foundation Trust
Manchester, M6 8HD
Department of Dermatology
Nuneaton, Warwickshire, CV10 7DJ
Brazil2 sites
Instituto de Dermatologia e Est�ca do Brasil LTDA - IDERJ
Rio de Janeiro, Rio de Janeiro, 22470-220
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-900
Slovakia2 sites
Univerzitna Nemocnica, Bratislava
Bratislava, 813 69
Fakultna Nemocnica Trnava
Trnava, 917 75
Finland1 site
Tampere University Hospital, Department of Dermatology and Venreology
Tampere, 33521
About this study
Official title: A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Conditions
- Psoriasis
- Being tested
- CP-690,550
- Keywords
- OPT Retreatment, OPT, chronic, moderate, severe, treatment, safety, treatment withdrawal, retreatment, retreatment withdrawal, CP-690,550, Psoriasis Vulgaris, Plaque Psoriasis, tofacitinib, Xeljanz, nail psoriasis, Jak-inhibitor, oral treatment, Pruritus, Itch
- Medical subject headings
- Psoriasis, Bronchiolitis Obliterans Syndrome, Lymphoma, Follicular, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-690,550Drug
10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
CP-690,550Drug
10 mg oral BID
CP-690,550Drug
5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
CP-690,550Drug
5 mg oral BID
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment (10 mg) BID / Placebo BID | Experimental | Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks Receives: Drug: CP-690,550 |
| Active Treatment (10 mg) BID | Experimental | Continuous active treatment (CP-690,550) for 56 weeks Receives: Drug: CP-690,550 |
| Active Treatment (5 mg) BID / Placebo BID | Experimental | Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks Receives: Drug: CP-690,550 |
| Active Treatment (5 mg) BID | Experimental | Continuous active treatment (CP-690,550) for 56 weeks Receives: Drug: CP-690,550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.
Measured: Weeks 4, 8 12, and 16 (Period B)
Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcomes (121)
Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)
PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.
Measured: Weeks 4 and 8 (Period B)
Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.
Measured: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
Measured: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C
PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
Measured: Weeks 4, 8, and 16 (Period C)
Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C
PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
Measured: Weeks 4, 8, and 16 (Period C)
Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C
PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)
PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)
PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)
PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)
PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Measured: Weeks 4, 8, and 16 (Period C)
Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)
PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)
PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Measured: Weeks 4, 8, and 16 (Period C)
Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)
Baseline defined as the last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Baseline defined as the last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Baseline was defined as the last observation until first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Baseline defined as the last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Baseline defined as the last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Baseline defined as the last observation up to first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Mean PASI Score During Initial CP-690,550 Treatment (Period A)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean PASI Score During the CP-690,550 Re-Treatment (Period C)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-B defined as last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-C defined as last observation up to first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A
PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A
PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A
PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C)
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C)
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)
PASI quantifies the severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)
PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, and 16 (Period C)
Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean ISI Score During the CP-690,550 Re-Treatment (Period C)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. Baseline-A defined as the last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. Baseline-B defined as the last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. Baseline-C defined as the last observation up to first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, and 16 (Period C)
ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, 16, and 24 (Period A)
ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, and 16 (Period C)
Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, and 16 (Period C)
ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, 16, and 24 (Period A)
ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, and 16 (Period C)
Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.
Measured: Weeks 4, 8, and 16 (Period C)
Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.
Measured: Weeks 4, 8, and 16 (Period C)
Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.
Measured: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, and 16 (Period C)
Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Measured: Weeks 4, 8, and 16 (Period C)
Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and standard deviations (SDs) of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.
Measured: Baseline and Week 24 (Period A)
Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.
Measured: Baseline and Week 56 (Period C)
Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.
Measured: Week 24 (Period A)
Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.
Measured: Week 56 (Period C)
Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Measured: Baseline and Week 24 (Period A)
Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.
Measured: Baseline and Week 56 (Period C)
Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-A defined as the last observation up to first dosing date in Period A.
Measured: Week 24 (Period A)
Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-C defined as the last observation up to first dosing date in Period C.
Measured: Week 56 (Period C)
Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe
Measured: Baseline and Weeks 4, 8, 16 and 24 (Period A)
Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.
Measured: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B)
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.
Measured: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.
Measured: Weeks 4, 8, 12, and 16 (Period B)
Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Measured: Weeks 4, 8, 16, and 24 (Period A)
Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Measured: Baseline and Week 56 (Period C)
Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-A defined as the last observation up to first dosing date in Period A.
Measured: Week 24 (Period A)
Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-C defined as the last observation up to first dosing date in Period C.
Measured: Week 56 (Period C)
Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Measured: Baseline and Week 24 (Period A)
Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Measured: Baseline and Week 56 (Period C)
Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Baseline-A defined as the last observation up to first dosing date in Period A.
Measured: Week 24 (Period A)
Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Baseline-C defined as the last observation up to first dosing date in Period C.
Measured: Week 56 (Period C)
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)
Measured: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)
Measured: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)
Measured: Weeks 4, 8, and 16 (Period C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186744
- Sponsor's protocol ID
- A3921111
- Status last verified
- Dec 2018
- First submitted
- 20 Aug 2010
- Last updated
- 26 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
PubMed 32816215Bissonnette R, Iversen L, Sofen H, Griffiths CE, Foley P, Romiti R, Bachinsky M, Rottinghaus ST, Tan H, Proulx J, Valdez H, Gupta P, Mallbris L, Wolk R. Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial. Br J Dermatol. 2015;172(5):1395-406. doi: 10.1111/bjd.13551. Epub 2015 Apr 2.
PubMed 25418186
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01186744
- Acronym / sponsor ID
- A3921111
- Conditions
- Psoriasis
- Keywords
- OPT Retreatment, OPT, chronic, moderate, severe, treatment, safety, treatment withdrawal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Treatment (10 mg) BID / Placebo BID | Experimental | Drug: CP-690,550Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks |
| Active Treatment (10 mg) BID | Experimental | Drug: CP-690,550Continuous active treatment (CP-690,550) for 56 weeks |
| Active Treatment (5 mg) BID / Placebo BID | Experimental | Drug: CP-690,550Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks |
| Active Treatment (5 mg) BID | Experimental | Drug: CP-690,550Continuous active treatment (CP-690,550) for 56 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
- Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
- No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.
Key exclusion criteria (3 listed)
- Non-plaque or drug induced forms of psoriasis;
- Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
- Any uncontrolled significant medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-690,55010 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design | Drug | Active Treatment (10 mg) BID / Placebo BID |
| CP-690,55010 mg oral BID | Drug | Active Treatment (10 mg) BID |
| CP-690,5505 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design | Drug | Active Treatment (5 mg) BID / Placebo BID |
| CP-690,5505 mg oral BID | Drug | Active Treatment (5 mg) BID |
Primary outcome
Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)
Time frame: Weeks 4, 8 12, and 16 (Period B)
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.
Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).
Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.
Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
121 secondary outcomes
Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)
Time frame: Weeks 4 and 8 (Period B)
Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
Time frame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
Time frame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C
Time frame: Weeks 4, 8, and 16 (Period C)
Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C
Time frame: Weeks 4, 8, and 16 (Period C)
Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)
Time frame: Weeks 4, 8, and 16 (Period C)
Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)
Time frame: Weeks 4, 8, and 16 (Period C)
Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)
Time frame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Time frame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Time frame: Weeks 4, 8, and 16 (Period C)
Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Time frame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Time frame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Time frame: Weeks 4, 8, and 16 (Period C)
Mean PASI Score During Initial CP-690,550 Treatment (Period A)
Time frame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)
Time frame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Mean PASI Score During the CP-690,550 Re-Treatment (Period C)
Time frame: Baseline and Weeks 4, 8, and 16 (Period C)
Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)
Time frame: Weeks 4, 8, 16, and 24 (Period A)
Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)
Time frame: Weeks 4, 8, 12, and 16 (Period B)
Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)
Time frame: Weeks 4, 8, and 16 (Period C)
Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Time frame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Time frame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32816215Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
- Derived from this study: PubMed 25418186Bissonnette R, Iversen L, Sofen H, Griffiths CE, Foley P, Romiti R, Bachinsky M, Rottinghaus ST, Tan H, Proulx J, Valdez H, Gupta P, Mallbris L, Wolk R. Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial. Br J Dermatol. 2015;172(5):1395-406. doi: 10.1111/bjd.13551. Epub 2015 Apr 2.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
87 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CP-690,550 in people with Psoriasis, run by Pfizer at 87 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Canada, Australia, Bulgaria, Argentina and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (time frame: Weeks 4, 8 12, and 16 (Period B)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186744, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.