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| Tracking Information | |||||
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| First Received Date ICMJE | May 17, 2002 | ||||
| Last Updated Date | February 20, 2008 | ||||
| Start Date ICMJE | July 2000 | ||||
| Primary Completion Date | November 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary outcome of the study was to evaluate the safety of anakinra [ Time Frame: 28 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The primary outcome of the study was to evaluate the safety of anakinra | ||||
| Change History | Complete list of historical versions of study NCT00037648 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Juvenile Rheumatoid Arthritis | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study | ||||
| Condition ICMJE | Juvenile Chronic Arthritis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 86 | ||||
| Completion Date | November 2003 | ||||
| Primary Completion Date | November 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | * Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis |
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| Gender | Both | ||||
| Ages | 2 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00037648 | ||||
| Responsible Party | Global Development Leader, Amgen Inc. | ||||
| Study ID Numbers ICMJE | 990758-990779 | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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