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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

Status: Completed

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.

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: 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)

Secondary outcome:

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

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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria:

- Between age 18 and 70 years

- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.

Exclusion Criteria:

- 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

Additional Information

Starting date: October 2007
Last updated: March 28, 2012

Page last updated: August 20, 2015

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