Juvenile Rheumatoid Arthritis
Primary Purpose
Juvenile Chronic Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Chronic Arthritis
Eligibility Criteria
Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
anakinra
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome of the study was to evaluate the safety of anakinra
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00037648
Brief Title
Juvenile Rheumatoid Arthritis
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 Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Chronic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
anakinra
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anakinra
Intervention Description
anakinra
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
The primary outcome of the study was to evaluate the safety of anakinra
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Juvenile Rheumatoid Arthritis
We'll reach out to this number within 24 hrs