Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial.
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 articleSubject
Administration, OralAdult
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/10161/10863Published Version (Please cite this version)
10.1186/s13063-015-0726-xPublication 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.
Collections
More Info
Show full item recordScholars@Duke
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

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info