Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis

Completed

• Conditions: Juvenile Rheumatoid Arthritis
• Interventions: Drug: Enbrel®

• Registration Number: NCT00078793
• Lead Sponsor: Amgen

Brief Summary

This study will evaluate long-term safety of etanercept with or without other DMARDs in children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or without other DMARDs.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2004-03-05
• Study First Submitted QC: 2004-03-08
• Study First Posted: 2004-03-09
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Methotrexate group	Enbrel®	Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept.

Primary Outcome Measures

Name	Time	Method
Adverse event rates and severity	36 months of observation

Secondary Outcome Measures

Name	Time	Method
Growth data and Tanner scores	36 months of observation