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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00037648 |
The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.
Condition | Intervention | Phase |
---|---|---|
Juvenile Chronic Arthritis |
Drug: Anakinra Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Randomized, Multi-Center, Blinded, Placebo-Controlled Study With an Open-Label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis |
Enrollment: | 86 |
Study Start Date: | July 2000 |
Study Completion Date: | November 2003 |
Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
placebo: Placebo Comparator |
Drug: Placebo
placebo
|
anakinra: Experimental |
Drug: Anakinra
anakinra
|
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 990758-990779 |
Study First Received: | May 17, 2002 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00037648 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Arthritis, Juvenile Rheumatoid Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Interleukin 1 Receptor Antagonist Protein Rheumatic Diseases |
Immune System Diseases Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |