Back to resultsColchicine for the Treatment of Osteoarthritis of the Knee (CLOAK)
Primary Purpose
Osteoarthritis, Osteo Arthritis Knee
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Colchicine 0.8 mg or 0.6 mg orally once daily
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
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).
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Colchicine
Arm Description
Placebo in capsule identical to study drug
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.
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03913442
Brief Title
Colchicine for the Treatment of Osteoarthritis of the Knee
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteo Arthritis Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in capsule identical to study drug
Arm Title
Colchicine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.8 mg or 0.6 mg orally once daily
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo 0.8 mg or 0.6 mg orally once daily for 3 months
Primary Outcome Measure Information:
Title
Difference in mean changes of VAS pain scores between treatment groups
Description
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."
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Mean changes and absolute differences in the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain
Description
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.
Time Frame
3 Months
Title
mean changes of KOOS stiffness
Description
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.
Time Frame
3 Months
Title
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.
Time Frame
3 Months
Title
mean changes of KOOS physical function
Description
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.
Time Frame
3 Months
Title
mean changes between total KOOS scores between and within the groups at 3 months.
Description
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.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Tse
Phone
646-501-7388
Email
Katherine.tse@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Pillinger, MD, FACP
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Apoorva Patil
Phone
646-501-7388
Email
apoorva.patil@nuulangone.org
First Name & Middle Initial & Last Name & Degree
Michael Pillinger, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing Access Criteria
Requests should be directed to Michael.pillinger@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Colchicine for the Treatment of Osteoarthritis of the Knee
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