NCT03780959

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Juvenile Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Etanercept	Administered twice weekly by subcutaneous injection
DRUG	Placebo	Administered twice weekly by subcutaneous injection

Timeline

• Start date: 1997-05-01
• Primary completion: 1998-07-08
• Completion: 1998-07-08
• First posted: 2018-12-19
• Last updated: 2019-08-02
• Results posted: 2019-08-02

Regulatory

• FDA-regulated drug study