Crohn's DiseasePhase 2NCT01393899
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
A Phase 2 study testing CP-690,550 in people with Crohn's Disease, run by Pfizer at 91 sites in 17 countries.
Trial summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- CP-690,550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 91 sitesin 17 countries
- Study dates
- Mar 2012to Jul 2015
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
- Women of childbearing potential must test negative for pregnancy prior to study enrolment.
Who cannot join
- Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
- Subjects likely to require any type of surgery during the study period.
- Fecal culture/toxin assay indicating presence of pathogenic infection.
Trial locations and contacts
91 sites in 17 countries.
91 sites in 17 countries
United States41 sites
ACMG Endoscopy Center
Anaheim, California, 92801
ACRI - Phase I, LLC
Anaheim, California, 92801
Advanced Clinical Research Institute-Phase 1, LLC
Anaheim, California, 92801
East Ann Arbor Health and Geriatrics Center
Ann Arbor, Michigan, 48109-2701
University of Michigan Health Systems
Ann Arbor, Michigan, 48109-5000
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, 20815
Metropolitan Gastroenterology Group, PC
Chevy Chase, Maryland, 20815
Gasteroenterology Consultants of Clearwater
Clearwater, Florida, 33756
West Coast Endoscopy Center
Clearwater, Florida, 33756
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Investigational Drug Services - University Hospitals Case Medical Center
Cleveland, Ohio, 44106
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
West Coast Clinical Trials
Cypress, California, 90630
Shands Endoscopy Center
Gainesville, Florida, 32608
Shands Hospital at the University of Florida
Gainesville, Florida, 32610-0214
Shands Medical Plaza and Cancer Center
Gainesville, Florida, 32610
University of Florida - College of Medicine
Gainsville, Florida, 32610
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, 11021
Clinical Research Of The Rockies
Lafayette, Colorado, 80026
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201
Great Lakes Gastroenterology
Mentor, Ohio, 44060
The Center for Digestive Health
Milwaukee, Wisconsin, 53215
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, 53215
Gastroenterology Group of Naples
Naples, Florida, 34102
Gulfshore Endoscopy Center (Endoscopies Only)
Naples, Florida, 34102
Cardiology Consultants
Norfolk, Virginia, 23502
Digestive & Liver Desease Specialists
Norfolk, Virginia, 23502
Alliance Clinical Research
Oceanside, California, 92056
North Florida Gastroenterology Research, LLC
Orange Park, Florida, 32073
Internal Medicine Specialists
Orlando, Florida, 32806
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601
University of Utah HSC
Salt Lake City, Utah, 84132
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606
Center for Digestive Health
Troy, Michigan, 48098
Surgical Centers of Michigan
Troy, Michigan, 48098
Digestive Health Specialists of Tyler
Tyler, Texas, 75701
Endoscopy Center of Tyler
Tyler, Texas, 75701
Metropolitan Gastroenterology Group, P C
Washington DC, Virginia, 20006
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226
GI Associates
Wauwatosa, Wisconsin, 53226
Hungary7 sites
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
Budapest, 1125
Pannonia Magánorvosi Centrum Kft
Budapest, 1136
Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium
Budapest, H-1044
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
Budapest, H-1076
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
Gyöngyös, 3200
Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium
Kaposvár, H-7400
Clinfan Kft.
Szekszárd, 7100
Canada5 sites
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G1A4
Office of Dr. David C. Pearson
Victoria, British Columbia, V8R 6R3
Office of Drs. Ranjith Andrew Singh and Jamie D. Papp,
Victoria, British Columbia, V8V 3P9
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3P9
Germany5 sites
Charite - Campus Berlin Mitte
Berlin, 10117
Charite - Campus Benjamin Franklin
Berlin, 12200
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
Berlin, 13353
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I
Ulm, 89081
Japan5 sites
Toho University Sakura Medical Center
Chiba, 285-8741
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Hokkaido, 060-0033
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501
Osaka City University Hospital
Osaka, Osaka, 545-8586
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520
Australia3 sites
Monash Medical Centre
Clayton, Victoria, 3168
Nepean Public Hospital
Kingswood, New South Wales, 2747
Royal Melbourne Hospital
Melbourne, 3050
Czechia3 sites
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012
Medial Pharma spol.s.r.o. (Pharmacy only)
Hradec Králové, 50012
RDG centrum s.r.o. (Radiology only)
Hradec Králové, 50012
Israel3 sites
Digestive Disease Institute
Jerusalem, 91031
Meir Medical Center
Kfar Saba, 44281
Tel Aviv Sourasky Medical Center
Tel Aviv, 64932
South Korea3 sites
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine
Seoul, 135-710
ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine
Seoul, 138-736
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Comite Etico de Investigacion Clinica
Barcelona, 08036
Hospital Universitario de La Princesa
Madrid, 28006
Ukraine3 sites
Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2
Donetsk, 83017
Municipal Institution "Odesa Regional Clinical Hospital", Odesa Regional Centre of Gastroenterology.
Odesa, 65117
Medical Clinical Research Center of Medical Center "Health Clinic" LLC
Vinnitsa, 21029
Bulgaria2 sites
4 MBAL Parvo vatreshno otdelenie
Sofia, 1000
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
Sofia, 1797
France2 sites
Hopital Huriez CHRU de Lille
Lille, 59037
Hôpital Haut-Lévêque/Service d hépato-gastroentérologie
Pessac, 33064
Netherlands2 sites
VU University Medical Center
Amsterdam, 1081HV
Academisch Medisch Centrum
Amsterdam, 1105 AZ
South Africa2 sites
Kingsbury Hospital
Cape Town, Western Cape, 7708
Parklands Medical Centre
Durban, 4091
Austria1 site
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, 1090
Greece1 site
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, 106 76
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
- Conditions
- Crohn's Disease
- Being tested
- Placebo, CP-690,550
- Keywords
- tofacitinib, Xeljanz, CP-690,550, maintenance therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
oral tablets twice daily
CP-690,550Drug
oral tablets twice daily
CP-690,550Drug
oral tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo BID | Placebo comparator | Not described Receives: Drug: Placebo |
| 5mg BID | Experimental | Not described Receives: Drug: CP-690,550 |
| 10mg BID | Experimental | Not described 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 With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Measured: Week 26
Secondary outcomes (15)
Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Weeks 4, 8, 12 and 20
Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Weeks 4, 8, 12, 20 and 26
Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Weeks 4, 8, 12, 20 and 26
Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Weeks 4, 8, 12, 20 and 26
Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Weeks 20 and 26
Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Weeks 20 and 26
CDAI Score by Week
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
Measured: Baseline and Weeks 4, 8, 12, 20 and 26
Change From Baseline in CDAI Score by Week
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
Measured: Weeks 4, 8, 12, 20 and 26
Kaplan-Meier Estimate of the Rate of Time to Relapse
Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Weeks 4, 8 12, 20 and 26
Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Measured: Week 26
C-Reactive Protein (CRP) by Week
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Measured: Baseline and Weeks 4, 8, 12, 20 and 26
Change From Baseline in CRP by Week
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Measured: Weeks 4, 8, 12, 20 and 26
Fecal Calprotectin by Week
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Measured: Baseline and Weeks 8, 12 and 26
Change From Baseline in Fecal Calprotectin by Week
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Measured: Weeks 8, 12 and 26
Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose
Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.
Measured: Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMar 2012
- Primary completionJul 2015
- Study completionJul 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT01393899
- Sponsor's protocol ID
- A3921084
- Other IDs
- 2011-001754-28
- Status last verified
- Nov 2016
- First submitted
- 12 Jul 2011
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.
PubMed 28209624
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01393899
- Acronym / sponsor ID
- A3921084
- Conditions
- Crohn's Disease
- Keywords
- tofacitinib, Xeljanz, CP-690,550, maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo BID | Placebo comparator | Drug: Placebo |
| 5mg BID | Experimental | Drug: CP-690,550 |
| 10mg BID | Experimental | Drug: CP-690,550 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
- Women of childbearing potential must test negative for pregnancy prior to study enrolment.
Key exclusion criteria (3 listed)
- Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
- Subjects likely to require any type of surgery during the study period.
- Fecal culture/toxin assay indicating presence of pathogenic infection.
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 |
|---|---|---|
| Placebooral tablets twice daily | Drug | Placebo BID |
| CP-690,550oral tablets twice daily | Drug | 5mg BID |
| CP-690,550oral tablets twice daily | Drug | 10mg BID |
Primary outcome
Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
Time frame: Week 26
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
15 secondary outcomes
Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
Time frame: Weeks 4, 8, 12 and 20
Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
Time frame: Weeks 4, 8, 12, 20 and 26
Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
Time frame: Weeks 4, 8, 12, 20 and 26
Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
Time frame: Weeks 4, 8, 12, 20 and 26
Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase
Time frame: Weeks 20 and 26
Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase
Time frame: Weeks 20 and 26
CDAI Score by Week
Time frame: Baseline and Weeks 4, 8, 12, 20 and 26
Change From Baseline in CDAI Score by Week
Time frame: Weeks 4, 8, 12, 20 and 26
Kaplan-Meier Estimate of the Rate of Time to Relapse
Time frame: Weeks 4, 8 12, 20 and 26
Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
Time frame: Week 26
C-Reactive Protein (CRP) by Week
Time frame: Baseline and Weeks 4, 8, 12, 20 and 26
Change From Baseline in CRP by Week
Time frame: Weeks 4, 8, 12, 20 and 26
Fecal Calprotectin by Week
Time frame: Baseline and Weeks 8, 12 and 26
Change From Baseline in Fecal Calprotectin by Week
Time frame: Weeks 8, 12 and 26
Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose
Time frame: Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28209624Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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
91 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-690,550 in people with Crohn's Disease, run by Pfizer at 91 sites in 17 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Hungary, Canada, Germany, Japan and 12 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Jan 2017). 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 With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26 (time frame: Week 26). 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 NCT01393899, which also lists 1 linked publication.
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 9 Jan 2017.