Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
This study has been terminated.
(the study was terminated because of slow enrollment)
Sponsor:
Amgen
Collaborator:
Immunex Corporation
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00078806
First received: March 5, 2004
Last updated: April 30, 2009
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Juvenile Rheumatoid Arthritis |
Drug: Enbrel Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis |
Resource links provided by NLM:
Genetics Home Reference related topics:
juvenile idiopathic arthritis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Determine the efficacy of etanercept in pediatric subjects with systemically active systemic onset juvenile rheumatoid arthritis [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine population pharmacokinetics for children with systemically active SOJRA at 0.4 mg/kg etanercept twice weekly and at 0.8 mg/kg twice weekly [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Determine the effect on the cytokine profile in a substudy [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Determine the time to response during open-label treatment with etanercept [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Determine the safety of etanercept in pediatric subjects with systemically active SOJRA [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Determine the mean time to flare (up to 3 months) following withdrawal of etanercept in Part-2 [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 13 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2001 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Enbrel |
Drug: Enbrel
Enbrel
|
| Placebo Comparator: Placebo |
Drug: Placebo
placebo
|
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00078806 History of Changes |
| Obsolete Identifiers: | NCT00039949 |
| Other Study ID Numbers: | 20021631 |
| Study First Received: | March 5, 2004 |
| Last Updated: | April 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Systemic Onset Juvenile Rheumatoid Arthiritis SOJRA Fever Rash Joint Pain |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases TNFR-Fc fusion protein Immunoglobulin G Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013