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Juvenile Rheumatoid Arthritis

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.
 
ClinicalTrials.gov Identifier: NCT00037648
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
Swedish Orphan Biovitrum

Study Description
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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.

Condition or disease Intervention/treatment Phase
Juvenile Chronic Arthritis Drug: Anakinra Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2000
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo Drug: Placebo
placebo
Experimental: anakinra Drug: Anakinra
anakinra


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome of the study was to evaluate the safety of anakinra [ Time Frame: 28 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00037648


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00037648    
Other Study ID Numbers: 990758-990779
First Posted: May 20, 2002    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: February 2008
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents