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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00078793

Enrollment

600

Registered

2004-03-09

Start date

2000-06-30

Completion date

2008-01-31

Last updated

2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Rheumatoid Arthritis

Keywords

JRA, Registry

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.

Interventions

DRUGEnbrel®

Etanercept alone, etanercept plus methotrexate or other DMARDs

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse event rates and severity	36 months of observation

Secondary

Measure	Time frame
Growth data and Tanner scores	36 months of observation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026