Juvenile Rheumatoid Arthritis - Full Text View

Sponsor:	Amgen
Information provided by:	Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:	NCT00037648

Purpose

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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Anakinra

U.S. FDA Resources

Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:

The primary outcome of the study was to evaluate the safety of anakinra [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

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 Comparator: placebo	Drug: Placebo placebo
Experimental: anakinra	Drug: Anakinra anakinra

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037648

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00037648 History of Changes
Other Study ID Numbers:	990758-990779
Study First Received:	May 17, 2002
Last Updated:	November 25, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases

Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012