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

Publication ,  Journal Article
Leung, Y-Y; Thumboo, J; Wong, SB; Haaland, B; Chowbay, B; Chakraborty, B; Tan, MH; Kraus, VB
Published in: Trials
2015

© Leung et al.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.

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Published In

Trials

DOI

ISSN

1745-6215

Publication Date

2015

Volume

16

Issue

1

Related Subject Headings

  • General & Internal Medicine
  • Cardiovascular System & Hematology
  • 4203 Health services and systems
  • 4202 Epidemiology
  • 3202 Clinical sciences
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology
 

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Leung, Y.-Y., Thumboo, J., Wong, S. B., Haaland, B., Chowbay, B., Chakraborty, B., … Kraus, V. B. (2015). Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): Study protocol for a randomized controlled trial. Trials, 16(1). https://doi.org/10.1186/s13063-015-0726-x
Leung, Y. -. Y., J. Thumboo, S. B. Wong, B. Haaland, B. Chowbay, B. Chakraborty, M. H. Tan, and V. B. Kraus. “Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): Study protocol for a randomized controlled trial.” Trials 16, no. 1 (2015). https://doi.org/10.1186/s13063-015-0726-x.
Leung, Y. .. Y., et al. “Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): Study protocol for a randomized controlled trial.” Trials, vol. 16, no. 1, 2015. Scival, doi:10.1186/s13063-015-0726-x.
Leung Y-Y, Thumboo J, Wong SB, Haaland B, Chowbay B, Chakraborty B, Tan MH, Kraus VB. Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): Study protocol for a randomized controlled trial. Trials. 2015;16(1).
Journal cover image

Published In

Trials

DOI

ISSN

1745-6215

Publication Date

2015

Volume

16

Issue

1

Related Subject Headings

  • General & Internal Medicine
  • Cardiovascular System & Hematology
  • 4203 Health services and systems
  • 4202 Epidemiology
  • 3202 Clinical sciences
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology