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

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Juvenile Rheumatoid Arthritis

Intervention: Enbrel® (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

Official title: Phase IV Registry of Etanercept (Enbrel) In Children With Juvenile Rheumatoid Arthritis

Study design: Case-Crossover, Prospective

Primary outcome: Adverse event rates and severity

Secondary outcome: Growth data and Tanner scores

Eligibility

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: June 2000
Ending date: August 2008
Last updated: February 20, 2008

Page last updated: June 20, 2008

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