Treatment for Patients With Osteoarthritis (OA) of the Knee
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Intra-Articular metHuIL-1ra (Anakinra) in Subjects With Osteoarthritis (OA) of the Knee
1 other identifier
interventional
165
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the clinical response in subjects with symptomatic OA of the knee following a single 50 mg anakinra, 150 mg anakinra or placebo intra-articular (IA) injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2004
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 16, 2005
CompletedFirst Posted
Study publicly available on registry
May 17, 2005
CompletedFebruary 22, 2008
February 1, 2008
8 months
May 16, 2005
February 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC
12 weeks
Secondary Outcomes (1)
Pain Patient's global assessment
12 weeks
Study Arms (2)
Anakinra
EXPERIMENTALanakinra
placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Chevalier X, Goupille P, Beaulieu AD, Burch FX, Bensen WG, Conrozier T, Loeuille D, Kivitz AJ, Silver D, Appleton BE. Intraarticular injection of anakinra in osteoarthritis of the knee: a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2009 Mar 15;61(3):344-52. doi: 10.1002/art.24096.
PMID: 19248129DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 16, 2005
First Posted
May 17, 2005
Study Start
June 1, 2004
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
February 22, 2008
Record last verified: 2008-02