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

Amgen600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Juvenile Rheumatoid Arthritis

Interventions

Enbrel®DRUG

Etanercept alone, etanercept plus methotrexate or other DMARDs

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

Adverse event rates and severity

Time frame: 36 months of observation

Secondary Outcomes

Growth data and Tanner scores

Time frame: 36 months of observation

Data from ClinicalTrials.gov

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