Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Etanercept (Drug); Placebo (Other)
Phase: Phase 4
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for
ciclosporin in patients with plaque psoriasis.
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Change From Randomization in PGA Score to Week 24
Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
Probability of Being Relapse Free During the 24 Weeks After Randomization
Percent (%) Change of PASI Score From Randomization to Week 24
Change From Randomization in DLQI to Week 24
DLQI at Each Visit From Baseline
Percentage of Rebound Effects
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.
Minimum age: 18 Years.
Maximum age: 70 Years.
- Between age 18 and 70 years
- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.
- Evidence of skin conditions other than psoriasis
- Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept,
anakinra, or any other systemic anti-psoriasis therapy or disease-modifying
antirheumatic drugs (DMARD) with 28 days of screening
- ultraviolet B (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
- Body mass index (BMI) > 38
- Pregnancy or Breastfeeding
- Significant concurrent medical conditions
Locations and Contacts
Starting date: October 2007
Last updated: March 28, 2012