Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
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/PostmarketDrugSafetyInformationforPatientsandProviders/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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02176460
Study Brief:
Protocol Section:
NCT02176460