Phase 4
N=120
Colchicine for the Treatment of Osteoarthritis of the Knee
Osteoarthritis · Osteo Arthritis Knee
Bottom Line
View on ClinicalTrials.gov: NCT03913442 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Visual Analog Scale (VAS) Pain Score — -1.45; -1.16 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Colchicine 0.8 mg or 0.6 mg orally once daily (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analog Scale (VAS) Pain Score |
-1.45; -1.16 | — |
| SECONDARY Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score |
9.5; 5.2 | — |
| SECONDARY Change in the KOOS Stiffness Score |
6.6; 5.5 | — |
| SECONDARY Change in the KOOS Physical Function Score |
9.8; 7.4 | — |
| SECONDARY Change in the KOOS Quality of Life Score |
6.9; 3.5 | — |
| SECONDARY Change in the KOOS Sports and Recreational Activities |
0.0; 2.8 | — |
| SECONDARY Change in the KOOS Total Score |
6.5; 4.9 | — |
| SECONDARY Number of Participants Who Used Acetaminophen or Other Medications for Pain |
16; 12 | — |
| SECONDARY Number of Participants Who Used Acetaminophen or Other Medications for Pain |
16; 12 | — |
| SECONDARY Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain |
-1; 1 | — |
| SECONDARY Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra) |
-66; -7.3 | — |
| SECONDARY Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2) |
100; 72.4 | — |
| SECONDARY Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion |
-1.2; -1.5 | — |
| SECONDARY Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US |
0; 0 | — |
| SECONDARY Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP) |
0.1; -4.7 | — |
| SECONDARY Change in Inflammatory Plasma Marker: Uric Acid |
0.2; -0.8 | — |
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).
Data sourced from ClinicalTrials.gov (NCT03913442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.