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Long-Term Safety of Etanercept in Psoriasis Extension Study
NCT00111436Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2003
- Primary completion
- Jul 2005
- Sponsor
- Amgen
- Modality
- Fc-Fusion Proteins
- Drugs
- etanercept
- Conditions
- psoriasis
01
Overview
Phase 3, open-label trial of etanercept in psoriasis (2 arms), sponsored by Amgen. Primary endpoints: Subject incidence of adverse events, including infectious episodes at 72 weeks and Changes from baseline in laboratory values at 72 weeks. Started Apr 2003; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
50 mg
Etanercept 50 mg once weekly
100 mg
Etanercept 50 mg twice weekly
03
Who it enrols
Adults with psoriasis who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642. Excludes active guttate, erythrodermic, or pustular psoriasis.
04
Endpoints
Primary
Subject incidence of adverse events, including infectious episodes
Changes from baseline in laboratory values
Secondary
Improvement in Psoriasis Area and Severity Index
Physician Global Assessment
Patient Global Assessment
Dermatology Life Quality Index
SF-36 Health Survey
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