Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00078793 |
Recruitment Status
:
Completed
First Posted
: March 9, 2004
Last Update Posted
: May 14, 2013
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Condition or disease | Intervention/treatment |
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Juvenile Rheumatoid Arthritis | Drug: Enbrel® |
Study Type : | Observational |
Actual Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis |
Study Start Date : | June 2000 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |
Group/Cohort | Intervention/treatment |
---|---|
Methotrexate group
Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept.
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Drug: Enbrel®
Etanercept alone, etanercept plus methotrexate or other DMARDs
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- Adverse event rates and severity [ Time Frame: 36 months of observation ]
- Growth data and Tanner scores [ Time Frame: 36 months of observation ]

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Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078793
Study Director: | MD | Amgen |
Additional Information:
Publications of Results:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00078793 History of Changes |
Obsolete Identifiers: | NCT00016575 |
Other Study ID Numbers: |
20021626 016.0026 |
First Posted: | March 9, 2004 Key Record Dates |
Last Update Posted: | May 14, 2013 |
Last Verified: | May 2013 |
Keywords provided by Amgen:
JRA Registry |
Additional relevant MeSH terms:
Arthritis Arthritis, Rheumatoid Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Etanercept Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
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 Analgesics, Non-Narcotic Analgesics Sensory System Agents |