Colchicine for the Treatment of Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

— CLOAK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913442
• Other study ID #: 16-01796
• Status: Completed
• Phase: Phase 4
• Start date: May 15, 2019
• Est. completion date: January 11, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Colchicine 0.8 mg or 0.6 mg orally once daily
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)
• Placebo oral capsule
Placebo 0.8 mg or 0.6 mg orally once daily for 3 months

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean changes of VAS pain scores between treatment groups	The VAS scale asks patients to rate the pain that they've had in each knee during the past 30 days on a scale of 0-10, where "0" means "No pain" and "10" means "Pain as bad as you can imagine."	3 Months
Secondary	Mean changes and absolute differences in the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain	The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.	3 Months
Secondary	mean changes of KOOS stiffness	The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.	3 Months
Secondary	mean absolute doses and changes in dosage of acetaminophen or other medications used for pain between and within the groups at baseline and 3 months.		3 Months
Secondary	mean changes of KOOS physical function	The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.	3 Months
Secondary	mean changes between total KOOS scores between and within the groups at 3 months.	The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.	3 Months