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Completed

NCT Number: NCT03913442

Colchicine for the Treatment of Osteoarthritis of the Knee

This prospective, double-blinded, placebo-controlled, randomized trial will enroll 120 SKOA subjects at the NYU Center for Musculoskeletal Care. Patients meeting entry criteria will be randomized 1:1 to treatment with colchicine or placebo daily for 3 months. Subjects will have detailed evaluation of standardized clinical pain outcomes, candidate peripheral blood biomarkers, baseline knee radiographs as well as MSK-US, and a subset will undergo evaluation of their synovial fluid.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteo Arthritis Knee Rheumatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are 40 years old or older
  • Continue to experience frequent knee symptoms as defined above
  • Have KL grade 2 or 3 on their last knee radiograph done for the parent study
  • Have an estimated glomerular filtration rate (eGFR) > 30 ml/min (MDRD equation) and liver transaminases < 2x the upper limit of normal
  • Have a BMI ≤ 32 at the time of enrollment
  • Agree to be randomized to take colchicine or placebo daily for 3 months

Exclusion criteria

  • Have received hyaluronic acid or corticosteroid steroid injection within the past 3 months
  • Have a diagnosis of gout/pseudogout or other inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthropathy etc).
  • Have a diagnosis of diabetes mellitus, chronic infectious disease, congestive heart failure, non-cutaneous cancer within the past 5 years
  • Plan on undergoing total knee replacement within the next 3 months
  • Be using any medication that is a strong CYP3A4 inhibitor whose metabolism may interact with colchicine (e.g., certain protease inhibitors, certain azole antifungal agents, clarithromycin).

Treatment and study plan

Colchicine 0.8 mg or 0.6 mg orally once daily

Drug

Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)

Placebo oral capsule

Drug

Placebo 0.8 mg or 0.6 mg orally once daily for 3 months

Primary outcomes

  1. Change in Visual Analog Scale (VAS) Pain Score

    Time frame: Baseline, 3 Months

    VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

Secondary outcomes

  1. Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score

    Time frame: Baseline, 3 Months

    The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The KOOS Pain Score refers to a specific subscale within the KOOS questionnaire that measures the severity of knee pain experienced by a patient, consisting of nine questions where each response is scored on a scale from 0 (no pain) to 4 (extreme pain), with a higher score indicating greater pain intensity; the overall pain score is then calculated as a percentage of the maximum possible score, where 0 represents the worst possible pain and 100 represents no pain at all.

  2. Change in the KOOS Stiffness Score

    Time frame: Baseline, 3 Months

    The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). Each item on the KOOS is scored on a scale from 0 (no problems) to 4 (extreme problems), and then the scores are calculated to generate a final score between 0 and 100. The KOOS stiffness score is a percentage from 0 to 100 that measures how much stiffness a patient experiences in their knee. A score of 0 indicates the most stiffness, while a score of 100 indicates no stiffness.

  3. Change in the KOOS Physical Function Score

    Time frame: Baseline, 3 Months

    The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Physical Function items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems. The scores for each dimension are then transformed to a scale from 0 to 100, where 0 represents extreme problems with knee function and 100 indicates no problems at all.

  4. Change in the KOOS Quality of Life Score

    Time frame: Baseline, 3 Months

    The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). A KOOS Quality of Life score ranges from 0 to 100, where 0 represents the worst possible knee-related quality of life and 100 indicates no problems at all. A higher score indicates better quality of life related to the knee.

  5. Change in the KOOS Sports and Recreational Activities

    Time frame: Baseline, 3 Months

    The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Sports and Recreational Activities 9 items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems relating to sports and recreational activities. The scores are then transformed to a scale from 0 to 100, with 100 indicating no knee problems with sports and recreational activities and 0 indicating extreme knee problems with sports and recreational activities .

  6. Change in the KOOS Total Score

    Time frame: Baseline, 3 Months

    The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  7. Number of Participants Who Used Acetaminophen or Other Medications for Pain

    Time frame: 6 weeks

  8. Number of Participants Who Used Acetaminophen or Other Medications for Pain

    Time frame: 3 Months

  9. Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain

    Time frame: 6 weeks, 3 months

  10. Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra)

    Time frame: Baseline, 3 months

  11. Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2)

    Time frame: Baseline, 3 months

  12. Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion

    Time frame: Baseline, 3 months

    Size of effusion is measured as millimeters

  13. Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US

    Time frame: Baseline, 3 months

  14. Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP)

    Time frame: Baseline, 3 months

  15. Change in Inflammatory Plasma Marker: Uric Acid

    Time frame: Baseline, 3 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Colchicine on Pain and Inflammation in Subjects With Knee Osteoarthritis

Acronym: CLOAK

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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