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Colchicine for the Treatment of Osteoarthritis of the Knee (CLOAK)

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ClinicalTrials.gov Identifier: NCT03913442
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Osteo Arthritis Knee Drug: Colchicine 0.8 mg orally once daily Drug: Placebo oral capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Colchicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo in capsule identical to study drug
Drug: Placebo oral capsule
Placebo 0.8 mg orally once daily for 3 months

Experimental: Colchicine
Colchicine 0.8 mg orally once daily
Drug: Colchicine 0.8 mg orally once daily
Colchicine 0.8 mg orally once daily for 3 months




Primary Outcome Measures :
  1. Difference in mean changes of VAS pain scores between treatment groups [ Time Frame: 3 Months ]
    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 :
  1. Mean changes and absolute differences in the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain [ Time Frame: 3 Months ]
  2. mean changes of KOOS stiffness [ Time Frame: 3 Months ]
  3. 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 ]
  4. mean changes of KOOS physical function [ Time Frame: 3 Months ]
  5. mean changes between total KOOS scores between and within the groups at 3 months. [ Time Frame: 3 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913442


Contacts
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Contact: Rebecca Cohen 1 212 598 6119 Rebecca.Cohen@nyulangone.org

Locations
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United States, New York
NYU Langone Health Not yet recruiting
New York, New York, United States, 10016
Contact: Rebecca Cohen    212-598-6119    Rebecca.Cohen@nyulangone.org   
Principal Investigator: Michael Pillinger, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Michael H Pillinger, MD, FACP New York Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03913442     History of Changes
Other Study ID Numbers: 16-01796
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents