Colchicine for the Treatment of Osteoarthritis of the Knee (CLOAK)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Gonarthrosis, Unspecified
  • Age: Between 40 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are capable of giving informed consent in English
    2. Subjects who are at least 40 years old
    3. Subjects who have a clinical diagnosis of knee OA
    4. Subjects who have frequent knee symptoms defined as pain, aching, or stiffness in or around one or both knees on most days (i.e. more than half) for at least one month in the past 12 months
    5. Subjects with KL grade of =1 demonstrated on knee radiograph, in at least one painful knee.
    6. Subjects with an estimated glomerular filtration rate (eGFR) > 30 ml/min (MDRD equation) and liver transaminases < 2x the upper limit of normal.
    7. Subjects with a BMI = 35kg/m2 at the time of enrollment.
    8. Subjects who will agree to refrain from taking oral or topical non-steroidal anti-inflammatory medications (NSAIDs) and intra-articular therapies to the knees for the duration of the study
    9. Subjects who will agree to refrain from changing the dose or frequency of any pain medication regimen (with the exception of acetaminophen), acupuncture, physical therapy or other nonpharmacologic modalities you are currently taking or participating in for the duration of the study.
    10. Subjects who are able to take colchicine or placebo daily for three months
    11. Female subjects of childbearing potential must use effective contraceptive protection (during the treatment period and 30 days after the last dose of study drug
    12. Male subjects who have female partners of child-bearing potential are required to be on effective contraceptive protection with their female partners during treatment period and for 90 days after the last dose of the study drug

You may not be eligible for this study if the following are true:

    1. Subjects who received hyaluronic acid or corticosteroid steroid injection within the past three months
    2. Subjects who have a known diagnosis of gout/pseudogout (acute calcium pyrophosphate arthropathy) or other inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthropathy etc).
    3. Subjects who have any clinical disorder that required the use of corticosteroids within one week of screening visit
    4. Subjects who have an estimated glomerular filtration rate (eGFR) < 30 ml/min (MDRD equation) and liver transaminases > 2x the upper limit of normal on most recent measurement
    5. Subjects who have a BMI > 35kg/m2 at the time of enrollment
    6. Subjects who have a diagnosis of diabetes mellitus, chronic infectious disease, congestive heart failure, noncutaneous cancer within the past 5 years or any other comorbidity that in the investigator’s opinion would disqualify the subject
    7. Subjects who are unwilling to refrain from any medication or herbal supplements that when taken with colchicine can lead to high levels of colchicine in the body within 14 days or 5 half-lives, whichever is longer, of the first administration of the study intervention in this study
    8. Subjects with scheduled or undergoing total knee replacement or other major surgery during the study period
    9. Subjects who are currently pregnant or plan to become pregnant during the study period
    10. Subjects who are unwilling to refrain from any medication or herbal supplements that is a strong CYP3A4 inhibitor whose metabolism may interact with colchicine within 14 days or 5 half-lives, whichever is longer, of the first administration of the study intervention in this study.
    11. Subjects who are unwilling to refrain from consuming grapefruit or grapefruit juice during the study period.
    12. Subjects who are unwilling to refrain from the use of more than 1 glass daily of red wine, or from consumption of Seville oranges, pomelos, exotic citrus fruits, or grapefruit hybrids from 7 days before the start of the study intervention
    13. Subjects who are unwilling to refrain from taking oral or topical NSAIDs during the study period.
    14. Subjects who are unwilling to refrain from receiving intra-articular therapies to the knees during the study period.
    15. Subjects who are unwilling to refrain from starting new pain medications (with the exception, including supplements, or acupuncture, physical therapy or other pain modalities for the duration of the study
    16. Subjects who are unwilling to be randomized to take colchicine or placebo daily for 3 months
    17. Subjects participating in other clinical studies or taking other investigational drugs
    18. Subjects who are nursing



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