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Clinical Trials/NCT00936065
NCT00936065CompletedPhase 4

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

Pfizer1 site in 1 country60 target enrollmentStarted: July 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Pfizer
Enrollment
60
Locations
1
Primary Endpoint
Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI
  • •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

Exclusion Criteria

  • •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.

Arms & Interventions

Group A

Active Comparator

Intervention: Etanercept (Drug)

Group B

Experimental

Intervention: Etanercept + Acitretin (Drug)

Group C

Active Comparator

Intervention: Acitretin (Drug)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24(Baseline, Weeks 2, 4, 8, 12, 18 and 24)
  • Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score(Weeks 2, 4, 8, 12, 18, and 24)
  • Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear(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(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(Baseline, Weeks 2, 4, 8, 12, 18 and 24)
  • Time to Achieve a PASI 50 Score(Baseline up to Week 24)
  • Time to Achieve a PASI 75 Score(Baseline up to Week 24)
  • Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild(Baseline up to Week 24)
  • Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear(Baseline up to Week 24)
  • Change From Baseline in the PGA of Psoriasis(Baseline, Weeks 2, 4, 8, 12, 18, and 24)
  • Change From Baseline in the PASI Score(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(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(Baseline, Weeks 2, 4, 8, 12 ,18 and 24)
  • Change From Baseline in SGA of Itching at Each Visit(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Baseline, Weeks 2, 4, 8, 12, 18 and 24)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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