Juvenile Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00037648

Recruitment Status : Completed

First Posted : May 20, 2002

Last Update Posted : November 26, 2009

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

Swedish Orphan Biovitrum

Tracking Information

First Submitted Date ^ICMJE

May 17, 2002

First Posted Date ^ICMJE

May 20, 2002

Last Update Posted Date

November 26, 2009

Study Start Date ^ICMJE

July 2000

Actual 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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

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 ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Juvenile Chronic Arthritis

Intervention ^ICMJE

Drug: Anakinra
anakinra
Drug: Placebo
placebo

Study Arms ^ICMJE

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

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

November 2003

Actual 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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

2 Years to 17 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

United States

Administrative Information

NCT Number ^ICMJE

NCT00037648

Other Study ID Numbers ^ICMJE

990758-990779

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Global Development Leader, Amgen Inc.

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

Amgen

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

PRS Account

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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