Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
Information source: Wyeth
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Etanercept (Drug); Placebo (Other)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for
ciclosporin in patients with plaque psoriasis.
Clinical Details
Official title: A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluation of change in PASI score from randomization to week 24
Secondary outcome: PASI Area under the Curve between randomization and week 24Change in PGA score % Relapse and time to relapse % Improvement in PASI score Change in DLQI Incidence of adverse events Rebound effects (worsening of psoriasis)
Detailed description:
The purpose of this study is to evaluate the efficacy and safety of etanercept as a
replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who
have achieved an adequate response with ciclosporin.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Between age 18 and 70 years
- Active and stable plaque psoriasis
Exclusion Criteria:
- Evidence of skin conditions other than psoriasis
- Psoralen plus PUVA, ciclosportin, acitretin, alefacept, anakinra, or any other
systemic anti-psoriasis therapy or DMARD with 28 days of screening
- UVB therapy, topical steroids, topical Vitamin A or D analog preparations, or
anthralin
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
- Corticosteroid dose of prednisone >10 mg/day
- Serious infection
- Receipt of any live vaccine
- Abnormal hematology or chemistry
- BMI > 38
- Pregnancy or Breast-feeding
- Significant concurrent medical conditions
Locations and Contacts
Additional Information
Starting date: October 2007
Ending date: December 2007
Last updated: December 21, 2007
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