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Juvenile Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00037648
First received: May 17, 2002
Last updated: November 25, 2009
Last verified: February 2008

May 17, 2002
November 25, 2009
July 2000
November 2003   (final data collection date for primary outcome measure)
The primary outcome of the study was to evaluate the safety of anakinra [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00037648 on ClinicalTrials.gov Archive Site
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Juvenile Rheumatoid Arthritis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Juvenile Chronic Arthritis
  • Drug: Anakinra
    anakinra
  • Drug: Placebo
    placebo
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
  • Experimental: anakinra
    Intervention: Drug: Anakinra
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
November 2003
November 2003   (final data collection date for primary outcome measure)
  • Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00037648
990758-990779
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Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Swedish Orphan Biovitrum
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP