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
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