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Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial.

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Date
2015-04-30
Authors
Leung, Ying-Ying
Thumboo, Julian
Wong, Bak Siew
Haaland, Ben
Chowbay, Balram
Chakraborty, Bibhas
Tan, Mann Hong
Kraus, Virginia B
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Abstract
BACKGROUND: Despite the high prevalence and global impact of knee osteoarthritis (KOA), current treatments are palliative. No disease modifying anti-osteoarthritic drug (DMOAD) has been approved. We recently demonstrated significant involvement of uric acid and activation of the innate immune response in osteoarthritis (OA) pathology and progression, suggesting that traditional gout therapy may be beneficial for OA. We therefore assess colchicine, an existing commercially available agent for gout, for a new therapeutic application in KOA. METHODS/DESIGN: COLKOA is a double-blind, placebo-controlled, randomized trial comparing a 16-week treatment with standard daily dose oral colchicine to placebo for KOA. A total of 120 participants with symptomatic KOA will be recruited from a single center in Singapore. The primary end point is 30% improvement in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at week 16. Secondary end points include improvement in pain, physical function, and quality of life and change in serum, urine and synovial fluid biomarkers of cartilage metabolism and inflammation. A magnetic resonance imaging (MRI) substudy will be conducted in 20 participants to evaluate change in synovitis. Logistic regression will be used to compare changes between groups in an intention-to-treat analysis. DISCUSSION: The COLKOA trial is designed to evaluate whether commercially available colchicine is effective for improving signs and symptoms of KOA, and reducing synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers. These biomarkers should provide insights into the underlying mechanism of therapeutic response. This trial will potentially provide data to support a new treatment option for KOA. TRIAL REGISTRATION: The trial has been registered at clinicaltrials.gov as NCT02176460 . Date of registration: 26 June 2014.
Type
Journal article
Subject
Administration, Oral
Adult
Aged
Anti-Inflammatory Agents
Biomarkers
Clinical Protocols
Colchicine
Double-Blind Method
Female
Humans
Inflammation Mediators
Intention to Treat Analysis
Knee Joint
Logistic Models
Magnetic Resonance Imaging
Male
Middle Aged
Osteoarthritis, Knee
Pain Measurement
Quality of Life
Recovery of Function
Research Design
Singapore
Surveys and Questionnaires
Synovial Fluid
Time Factors
Treatment Outcome
Young Adult
Permalink
https://hdl.handle.net/10161/10863
Published Version (Please cite this version)
10.1186/s13063-015-0726-x
Publication Info
Leung, Ying-Ying; Thumboo, Julian; Wong, Bak Siew; Haaland, Ben; Chowbay, Balram; Chakraborty, Bibhas; ... Kraus, Virginia B (2015). Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial. Trials, 16. pp. 200. 10.1186/s13063-015-0726-x. Retrieved from https://hdl.handle.net/10161/10863.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Kraus

Virginia Byers Kraus

Professor of Medicine
My special area of expertise is as a clinician scientist investigating osteoarthritis. Osteoarthritis is the most common form of joint disease in man and its incidence increases with age. It is a problem of increasing concern to the medical community due to the increasing longevity of the population. Trained as a molecular biologist and a Rheumatologist, I endeavor to study this disease from bedside to bench. The work in this laboratory focuses on osteoarthritis and deals w
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