Clinical trial: Colchicine for Symptom and Inflammation in Knee Osteoarthritis (NCT02176460)

Eligibility criteria:
Inclusion Criteria:

          -  Symptomatic knee OA meeting American College of Rheumatology (ACR) criteria

          -  Radiographic criteria for knee OA with Kellgren-Lawrence (KL) stage of ≥ 2 in at least
             one knee

          -  Response positive to the question "do you have pain, aching or stiffness of the knee
             on most days of the past month

          -  Score of ≥ 40 out of 100 on a visual analogue scale (VAS) for pain

          -  Age ≥ 21 years or above

          -  Male and female subjects and all ethnicities included

          -  Patients to agree to avoid consuming grapefruit and grapefruit juice while using
             colchicine

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Exposure to a corticosteroid (either parenteral or oral) within 3 months prior to the
             study enrolment

          -  Knee arthroscopic surgery within 6 months prior to the study enrolment

          -  Known history of avascular necrosis, inflammatory arthritis (e.g. Rheumatoid
             Arthritis), Paget's disease, joint infection, periarticular fracture, neuropathic
             arthropathy, Reiter's syndrome, or gout involving the knee

          -  Contraindication to arthrocentesis (warfarin use, bleeding disorder, skin rash or skin
             infection of signal knee)

          -  Knee joint replacement;

          -  History of podagra, active gout or treatment for gout

          -  Pregnancy or lactation - women of childbearing potential will have serum pregnancy
             testing (ßHCG) at time of entry prior to any imaging studies (X-ray or MRI); female
             subjects of childbearing potential must agree to use some form of contraception during
             the 16 week trial and for 1 week after the end of the trial (over 6 half-life
             equivalents)

          -  Renal failure with serum creatinine > 150mmol/L (1.7 mg/dL);

          -  Hepatic impairment defined by serum alanine transaminase (ALT) above the upper limit
             of normal for the clinical laboratory performing the screening test

          -  Muscle impairment defined by elevated serum creatine phosphokinase (CPK) above the
             upper limit of normal for the clinical laboratory performing the screening test

          -  Personnel directly affiliated with this study or their immediate family members
             (defined as a spouse, parent, child or sibling, whether biological or legally adopted)

          -  Current enrolment in or discontinued within the last 30 days from a clinical trial
             involving an off-label use of an investigational drug or device, or are concurrently
             enrolled in any other type of medical research judged to be scientifically or
             medically incompatible with this study

          -  Inability to understand and cooperate with the investigators or to give valid consent;

          -  Contraindication for magnetic resonance imaging (MRI) - this is exclusion only for the
             subset of individuals selected for this imaging procedure;

          -  Anticipation of need for joint replacement within 4 months of the start of the
             intervention;

          -  Current treatment with drugs known to inhibit Cytochrome 450(3A4) isoforms and/or
             P-glycoprotein (P-gp) that increase the risk of colchicine-induced toxic effects (see:
             http://www.fda.gov/Drugs/Drug-safety/PostmarketDrugSafetyInformationforPatientsandProv
             iders/DrugSafetyInformationforHeathcareProfessionals/ucm174315.htm).

        Inclusion can be considered after 14 day wash out of agents listed in the drug information
        sheet, but only if treatment in the near future with one of these agents is not
        anticipated. The clinical necessity for such treatments during the study will require
        immediate discontinuation of the study drug and conversion of the patient to standard care.
        However, the patient will remain on study and scheduled measurements taken. Analyses will
        be performed on an intention-to-treat basis.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment