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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 24

Change 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

Page last updated: March 21, 2008

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