Clinical trial NCT03913442: Colchicine for the Treatment of Osteoarthritis of the Knee
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Osteo Arthritis Knee
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Pain Score
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
timeFrame: Baseline, 3 Months
measure: Change in the KOOS Stiffness Score
timeFrame: Baseline, 3 Months
measure: Change in the KOOS Physical Function Score
timeFrame: Baseline, 3 Months
measure: Change in the KOOS Quality of Life Score
timeFrame: Baseline, 3 Months
measure: Change in the KOOS Sports and Recreational Activities
timeFrame: Baseline, 3 Months
measure: Change in the KOOS Total Score
timeFrame: Baseline, 3 Months
measure: Number of Participants Who Used Acetaminophen or Other Medications for Pain
timeFrame: 6 weeks
measure: Number of Participants Who Used Acetaminophen or Other Medications for Pain
timeFrame: 3 Months
measure: Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain
timeFrame: 6 weeks, 3 months
measure: Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra)
timeFrame: Baseline, 3 months
measure: Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2)
timeFrame: Baseline, 3 months
measure: Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion
timeFrame: Baseline, 3 months
measure: Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US
timeFrame: Baseline, 3 months
measure: Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP)
timeFrame: Baseline, 3 months
measure: Change in Inflammatory Plasma Marker: Uric Acid
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Michael H Pillinger, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References: