Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)

Juvenile Rheumatoid Arthritis Clinical Trial

Official title: Safety, Population Pharmacokinetics, and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) in Children With Juvenile Rheumatoid Arthritis

Status Completed

Clinical Trial Summary

The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.

Clinical Trial Description

This was a two-part study. In the first part of the study, all participants received open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with disease response as defined by the JRA Definition of Improvement (DOI) using the JRA Core Set Criteria were randomized in part 2 of the study to receive placebo or continued administration of etanercept until either disease flare occurred or 4 months elapsed, whichever was earlier.

Participants who did not meet the DOI at day 90, participants who had disease flare during part 2 and participants who completed the blinded part of the study were eligible to receive open-label treatment with etanercept under protocol 16.0018 (NCT00357903). ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Rheumatoid Arthritis
• Necrosis

• NCT number: NCT03780959
• Study type: Interventional
• Source: Amgen
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 1997
• Completion date: July 8, 1998