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Juvenile Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037648
First Posted: May 20, 2002
Last Update Posted: November 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Swedish Orphan Biovitrum
May 17, 2002
May 20, 2002
November 26, 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 ]
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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.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
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United States
 
NCT00037648
990758-990779
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Global Development Leader, Amgen Inc.
Amgen
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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