Study Complete
Sponsor ID
20050111
Pediatric Open-Label Extension Study of Etanercept in Patients with Plaque Psoriasis
Study Details
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
Protocol Summary
Primary Outcome Measures
Subject incidence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes
Timeframe: 168 Weeks
Secondary Outcome Measures
Injection site reactions
Timeframe: 168 Weeks
exposure adjusted event rates for adverse events
Timeframe: 168 Weeks
infections and injection site reactions
Timeframe: 168 weeks
physical examination
Timeframe: 168 weeks
vital signs
Timeframe: 168 weeks
laboratory toxicities
Timeframe: 168 weeks
anti-etanercept antibodies
Timeframe: 168 weeks
PASI 50
Timeframe: 168 weeks
PASI 75
Timeframe: 168 weeks
PASI 90
Timeframe: 168 weeks
Clear or almost clear status of sPGA
Timeframe: 168 weeks
percent improvement in CDLQI
Timeframe: 168 Weeks
improvement from baseline in joint pain
Timeframe: 168 weeks
Percent improvement in PASI score
Timeframe: 168 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.