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

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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Key information

Conditions

Juvenile Rheumatoid Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enbrel®

Drug

Etanercept alone, etanercept plus methotrexate or other DMARDs

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

Immunex Corporation

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2008
Study completion: 2008
First posted: Mar 9, 2004
Registry last updated: May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed