Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Etanercept (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Summary
The purpose of this study is to evaluate the safety and tolerability of long-term
administration of etanercept in adults with psoriasis who have participated in previous
etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy
of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis
studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly
(if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72
weeks.
Clinical Details
Official title: An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Primary outcome: Subject incidence of adverse events, including infectious episodesChanges from baseline in laboratory values
Secondary outcome: Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original studyProportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis Patient Global Assessment of psoriasis Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores Changes from baseline in SF-36 Health Survey scores
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects who were randomized and received at least one dose of investigational product in
Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of
this protocol)
Exclusion Criteria:
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening
visit
- Pregnant or breast-feeding females
- Evidence of skin conditions at the time of the screening visit (e. g., eczema) that
would interfere with evaluations of the effect of the investigational product on
psoriasis
Locations and Contacts
Additional Information
AmgenTrials clinical trials website Notice regarding posted summaries of trial results To access clinical trial results information click on this link
Starting date: April 2003
Ending date: July 2005
Last updated: February 20, 2008
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