An Observational Open Label Single Arm Single-Center Study of the Effects of Colchicine on Pain and Inflammation in Subjects with Hand Osteoarthritis

Are you eligible to participate in this study?

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

  • Conditions:
    Hand Osteoarthritis
  • Age: Between 40 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants will provide written informed consent
    2. Have a clinical diagnosis of hand OA as per ACR criteria
    3. Have frequent hand symptoms in at least 2 IP joints defined as pain, aching, or stiffness on most days
    4. Have prior hand radiographs with OA in =2 IP joints
    5. VAS pain greater than or equal to 30mm in at least one hand in the month prior to the screening visit.
    6. Have an estimated glomerular filtration rate (eGFR) > 30 ml/min (MDRD equation) and liver transaminases <2x the upper limit of normal
    7. Agree to try to refrain from taking new oral or topical non-steroidal anti-inflammatory medications (NSAIDs) and intra-articular therapies to the fingers for the duration of the study
    8. Agree to try to refrain from changing the dose or frequency of any pain medication regimen, acupuncture, physical therapy or other nonpharmacologic modalities the subject is currently taking for the duration of the study
    9. Agree to follow treating physician’s advice to take 0.6mg colchicine daily or twice daily for at least 30 days

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

    1. Have received intra-articular therapies to the hand within the past three months prior
    2. Have a known diagnosis of gout/pseudogout or other inflammatory arthritis
    3. Have any clinical disorder that required the use of corticosteroids within one week of screening
    4. Have an estimated glomerular filtration rate (eGFR) < 30 ml/min (MDRD equation) and/or liver transaminases > 2x the upper limit of normal on most recent measurement
    5. Have any other comorbidity that in the investigator or clinician’s opinion would disqualify the subject
    6. Scheduled major surgery during the study period
    7. Those participating in other clinical studies or taking investigational drugs
    8. Terminally ill participants
    9. Prescribed colchicine at doses other than 0.6mg daily or twice daily
    10. Actively taking colchicine
    11. Have previously taken colchicine for treatment of hand OA
    12. Pregnant



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