Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis

• Status: Terminated
• Trial end date: 2004-05-06
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Immunex Corporation
• Treatments: Etanercept

Criteria

INCLUSION CRITERIA:

• 2 - 18 years of age

• SOJRA for at least 3 months, with stable systemic features

• If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable

• Must take prednisone at a stable dose

EXCLUSION CRITERIA:

• Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids

• Pregnant or nursing female

• Clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology

• Previous receipt of any tumor necrosis factor (TNF) inhibitor

• Live virus vaccine within 12 weeks of study entry

• Participation in another study requiring informed consent within 12 weeks of entry

• Diabetes that requires insulin treatment

• Infection, chronic, recurrent, or currently active

• Any serious medical or psychiatric condition or history of alcohol or drug abuse