Moderate to Severe PsoriasisPhase 4NCT00936065
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
A Phase 4 study testing Etanercept, Etanercept + Acitretin and Acitretin in people with Moderate to Severe Psoriasis, run by Pfizer at 10 sites in South Korea.
Trial summary
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Psoriasis
- What is being tested?
- Etanercept, Etanercept + Acitretin and Acitretin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Jul 2009to Apr 2011
- Phase
- Phase 4
- 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
- Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
- In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
- Negative urine pregnancy test before the first dose of study drug in all female patients
Who cannot join
- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
- Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Pfizer Investigational Site
Daejeon, Korea, 301 721
Pfizer Investigational Site
Gyeonggido, Korea, 420 717
Pfizer Investigational Site
S0, Seoul, 137-701
Pfizer Investigational Site
Seoul, Korea, 110 744
Pfizer Investigational Site
Seoul, Korea, 130 702
Pfizer Investigational Site
Seoul, Korea, 137 701
Pfizer Investigational Site
Seoul, Korea, 152 703
Pfizer Investigational Site
Seoul, Seoul, 431-070
Pfizer Investigational Site
Seoul, 135 710
Pfizer Investigational Site
Seoul, 138 736
About this study
Official title: A Multicenter, Randomized, Open Pilot Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly Followed Etanercept 25mg Twice Weekly, the Combination of Etanercept 25 mg Twice Weekly and Acitretin and Acitretin Alone in Patients With Moderate to Severe Psoriasis
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
- Conditions
- Moderate to Severe Psoriasis
- Being tested
- Etanercept, Etanercept + Acitretin, Acitretin
- Keywords
- Etanercept, Acitretin, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Etanercept 50mg followed by 25mg
Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks
Etanercept + AcitretinDrug
Also called Etancercept 25mg and Acitretin 10mg
Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks
AcitretinDrug
Also called Acitretin 10mg
Acitretin at a dose of 10mg BID for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: Drug: Etanercept |
| Group B | Experimental | Not described Receives: Drug: Etanercept + Acitretin |
| Group C | Active comparator | Not described Receives: Drug: Acitretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Measured: Week 24
Secondary outcomes (32)
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Measured: Weeks 2, 4, 8, 12, 18, and 24
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence).
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Time to Achieve a PASI 50 Score
PASI 50 defined as a 50% or greater improvement in PASI score from Baseline
Measured: Baseline up to Week 24
Time to Achieve a PASI 75 Score
PASI 75 defined as a 75% or greater improvement in PASI score from Baseline
Measured: Baseline up to Week 24
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).
Measured: Baseline up to Week 24
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Measured: Baseline up to Week 24
Change From Baseline in the PGA of Psoriasis
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18, and 24
Change From Baseline in the PASI Score
Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Change From Baseline in SGA of Itching at Each Visit
Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement "I would like to continue with my current psoriasis treatment". Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory?" Percentage of participants who responded "yes" reported.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory?" Percentage of participants who responded "yes" reported.
Measured: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2011
- Study completionApr 2011
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 Moderate to Severe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT00936065
- Sponsor's protocol ID
- 0881A6-4625
- Other IDs
- B1801065
- Status last verified
- Mar 2012
- First submitted
- 7 Jul 2009
- Last updated
- 9 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lee JH, Youn JI, Kim TY, Choi JH, Park CJ, Choe YB, Song HJ, Kim NI, Kim KJ, Lee JH, Yoo HJ. A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis. BMC Dermatol. 2016 Jul 25;16(1):11. doi: 10.1186/s12895-016-0048-z.
PubMed 27455955
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Pilot Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly Followed Etanercept 25mg Twice Weekly, the Combination of Etanercept 25 mg Twice Weekly and Acitretin and Acitretin Alone in Patients With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00936065
- Acronym / sponsor ID
- 0881A6-4625
- Conditions
- Moderate to Severe Psoriasis
- Keywords
- Etanercept, Acitretin, Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Posted 9 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Etanercept |
| Group B | Experimental | Drug: Etanercept + Acitretin |
| Group C | Active comparator | Drug: Acitretin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
- In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
- Negative urine pregnancy test before the first dose of study drug in all female patients
Key exclusion criteria (3 listed)
- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
- Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
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 |
|---|---|---|
| EtanerceptAlso: Etanercept 50mg followed by 25mgEtanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks | Drug | Group A |
| Etanercept + AcitretinAlso: Etancercept 25mg and Acitretin 10mgCombination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks | Drug | Group B |
| AcitretinAlso: Acitretin 10mgAcitretin at a dose of 10mg BID for 24 weeks | Drug | Group C |
Primary outcome
Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
Time frame: Week 24
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
32 secondary outcomes
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Time frame: Weeks 2, 4, 8, 12, 18, and 24
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Time to Achieve a PASI 50 Score
Time frame: Baseline up to Week 24
Time to Achieve a PASI 75 Score
Time frame: Baseline up to Week 24
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Time frame: Baseline up to Week 24
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
Time frame: Baseline up to Week 24
Change From Baseline in the PGA of Psoriasis
Time frame: Baseline, Weeks 2, 4, 8, 12, 18, and 24
Change From Baseline in the PASI Score
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Change From Baseline in SGA of Itching at Each Visit
Time frame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27455955Lee JH, Youn JI, Kim TY, Choi JH, Park CJ, Choe YB, Song HJ, Kim NI, Kim KJ, Lee JH, Yoo HJ. A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis. BMC Dermatol. 2016 Jul 25;16(1):11. doi: 10.1186/s12895-016-0048-z.
- 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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept, Etanercept + Acitretin and Acitretin in people with Moderate to Severe Psoriasis, run by Pfizer at 10 sites in South Korea.
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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Apr 2012). 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 Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (time frame: Week 24). 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 NCT00936065, 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 Apr 2012.