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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-06-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Juvenile Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Methotrexate group

Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept.

Enbrel®

Intervention Type DRUG

Etanercept alone, etanercept plus methotrexate or other DMARDs

Interventions

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Enbrel®

Etanercept alone, etanercept plus methotrexate or other DMARDs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* JRA by American College of Rheumatology (ACR) criteria - Active joints - Initiate etanercept alone, etanercept plus methotrexate or other DMARDs, methotrexate alone, or methotrexate with other DMARDs within 6 months of entry into Registry
* Polyarticular or systemic RA in 3 or more joints at start of treatment

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No