Status:
TERMINATED
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Lead Sponsor:
Amgen
Collaborating Sponsors:
Immunex Corporation
Conditions:
Juvenile Rheumatoid Arthritis
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief 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).
Detailed Description
Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 mon...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 4 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2004
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00078806
Start Date
June 4 2001
End Date
May 6 2004
Last Update
September 25 2019
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