Colchicine for the Treatment of Osteoarthritis of the Knee

NCT03913442 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-01796
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS) Pain Score

  VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

  Baseline, 3 Months

Secondary Outcomes (15)

• Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score

  Baseline, 3 Months

• Change in the KOOS Stiffness Score

  Baseline, 3 Months

• Change in the KOOS Physical Function Score

  Baseline, 3 Months

• Change in the KOOS Quality of Life Score

  Baseline, 3 Months

• Change in the KOOS Sports and Recreational Activities

  Baseline, 3 Months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo in capsule identical to study drug

Drug: Placebo oral capsule

Colchicine

EXPERIMENTAL

0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses.

Drug: Colchicine 0.8 mg or 0.6 mg orally once daily

Interventions

Colchicine 0.8 mg or 0.6 mg orally once daily DRUG

Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)

Colchicine

Placebo oral capsule DRUG

Placebo 0.8 mg or 0.6 mg orally once daily for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Michael H Pillinger, MD, FACP
• Organization: NYU Langone Health

Michael.Pillinger@nyulangone.org

646-501-2722

Study Officials

• Michael H Pillinger, MD, FACP

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 12, 2019
• Study Start: May 15, 2019
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Requests should be directed to Michael.pillinger@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)