Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Juvenile Rheumatoid Arthritis
Intervention: Enbrel (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Summary
Rationale: etanercept inhibits the effects of tumor necrosis factor, which plays an
important role in the progression of rheumatoid arthritis. A study of children with
polyarticular course juvenile rheumatoid arthritis showed that Enbrel had efficacy and was
generally well tolerated in children ages 4-17 who had moderately to severely active disease
and who failed treatment with one or more disease modifying antiarthritic drugs. The
children in the study may have had arthritis onset of pauciarticular, polyarticular, or
systemic nature. Systemic onset juvenile rheumatoid arthritis (SOJRA) may result in
approximately one-third of patients having significant long-term disability. Purpose: the
Phase 4 study is designed to further define the safety and efficacy of etanercept in those
children with SOJRA.
Clinical Details
Official title: Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Determine the efficacy of etanercept in pediatric subjects with systemically active systemic onset juvenile rheumatoid arthritis
Secondary outcome: Determine population pharmacokinetics for children with systemically active SOJRA at 0.4 mg/kg etanercept twice weekly and at 0.8 mg/kg twice weeklyDetermine the effect on the cytokine profile in a substudy Determine the time to response during open-label treatment with etanercept Determine the safety of etanercept in pediatric subjects with systemically active SOJRA Determine the mean time to flare (up to 3 months) following withdrawal of etanercept in Part-2 Determine the safety and benefit of higher doses of etanercept (up to 0.8 mg/kg twice weekly) in Part-1B for children who have had a partial response to etanercept at 0.4 mg/kg twice weekly in Part-1A
Eligibility
Minimum age: 2 Years.
Maximum age: 18 Years.
Gender(s): Both.
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 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
Locations and Contacts
Additional Information
AmgenTrials clinical trials website Notice regarding posted summaries of trial results To access clinical trial results information click on this link FDA-approved Drug Labeling
Starting date: June 2001
Last updated: April 30, 2009
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