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

Amgen

Status: Completed

Conditions: Juvenile Rheumatoid Arthritis

Treatments: Drug: Enbrel®

Study type: Observational

Funder types: Industry

Identifiers

NCT00078793

016.0026

20021626

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

600 participants in 1 patient group

Methotrexate group

Description:

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

Treatment:

Drug: Enbrel®