Terminated/Withdrawn
Sponsor ID
20021631
Safety and Efficacy Study of Etanercept (Enbrel®) In Children with Systemic Onset Juvenile Rheumatoid Arthritis
Study Details
The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).
Protocol Summary
Primary Outcome Measures
Determine the efficacy of etanercept in pediatric subjects with systemically active systemic onset juvenile rheumatoid arthritis
Timeframe: 13 months
Secondary Outcome Measures
Determine population pharmacokinetics for children with systemically active SOJRA at 0.4 mg/kg etanercept twice weekly and at 0.8 mg/kg twice weekly
Timeframe: 13 months
Determine the effect on the cytokine profile in a substudy
Timeframe: 13 months
Determine the time to response during open-label treatment with etanercept
Timeframe: 13 months
Determine the safety of etanercept in pediatric subjects with systemically active SOJRA
Timeframe: 13 months
Determine the mean time to flare (up to 3 months) following withdrawal of etanercept in Part-2
Timeframe: 13 months
Determine the safety and benefit of higher doses of etanercept (up to 0.8 mg/kg twice weekly) in Part-1B for children who have had a partial response to etanercept at 0.4 mg/kg twice weekly in Part-1A
Timeframe: 13 months
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.