Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis
This study has been completed.
Sponsor:
Amgen
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00078793
First received: March 5, 2004
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Juvenile Rheumatoid Arthritis |
Drug: Enbrel® |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Adverse event rates and severity [ Time Frame: 36 months of observation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Growth data and Tanner scores [ Time Frame: 36 months of observation ] [ Designated as safety issue: Yes ]
| Enrollment: | 600 |
| Study Start Date: | June 2000 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Methotrexate group
Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept.
|
Drug: Enbrel®
Etanercept alone, etanercept plus methotrexate or other DMARDs
|
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric subjects age 2 to < or = 18 years of age with polyarticular course or systemic JRA who have recently started and are currently receiving: etanercept alone or in combination with methotrexate or other DMARDs; methotrexate alone or in combination with other DMARDs.The population includes pediatric subjects who completed Immunex protocol 016.0028 and selected other Immunex protocols will be eligible for this study once they change to marketed etanercept.
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00078793 History of Changes |
| Other Study ID Numbers: | 20021626, 016.0026 |
| Study First Received: | March 5, 2004 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
JRA Registry |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate TNFR-Fc fusion protein Immunoglobulin G Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents, Non-Steroidal |
ClinicalTrials.gov processed this record on May 22, 2013