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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 17, 2002

Last Updated Date

November 25, 2009

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

Not Provided

Change History

Complete list of historical versions of study NCT00037648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Juvenile Chronic Arthritis

Intervention ^ICMJE

Drug: Anakinra
anakinra
Drug: Placebo
placebo

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00037648

Other Study ID Numbers ^ICMJE

990758-990779

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Swedish Orphan Biovitrum

Verification Date

February 2008

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

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