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Anti-inflammatory

Colchicine for Osteoarthritis (CLOAK Trial)

Phase 4
Waitlist Available
Led By Michael H Pillinger, MD, FACP
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an estimated glomerular filtration rate (eGFR) > 30 ml/min (MDRD equation) and liver transaminases < 2x the upper limit of normal
Are 40 years old or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

CLOAK Trial Summary

This trialwill evaluate if colchicine can improve knee osteoarthritis symptoms and look at biomarkers and imaging to help understand how it works.

Who is the study for?
This trial is for individuals over 40 with a BMI ≤ 32 and moderate knee osteoarthritis, who still have frequent knee pain. They must have normal kidney and liver function and agree to take colchicine or a placebo daily for 3 months. It's not for those with gout, other arthritis types, diabetes, heart failure, recent cancer, planned knee surgery soon, or recent joint injections.Check my eligibility
What is being tested?
The study tests if Colchicine (0.6 mg or 0.8 mg) taken once daily can reduce pain in knee osteoarthritis compared to a placebo. Participants are randomly assigned to either the drug or placebo group and monitored over three months at NYU's Center for Musculoskeletal Care.See study design
What are the potential side effects?
Colchicine may cause side effects such as digestive issues (nausea, diarrhea), blood disorders (low white cells), muscle weakness/pain; however specific side effects will be closely monitored throughout the trial.

CLOAK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good and my liver tests are within normal limits.
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I am 40 years old or older.

CLOAK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in mean changes of VAS pain scores between treatment groups
Secondary outcome measures
Mean changes and absolute differences in the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain
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 between total KOOS scores between and within the groups at 3 months.
+2 more

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981
1%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine
Placebo

CLOAK Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ColchicineExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Placebo in capsule identical to study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine 0.8 mg or 0.6 mg orally once daily
2019
Completed Phase 4
~120

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,601 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,005 Patients Enrolled for Osteoarthritis
Michael H Pillinger, MD, FACPPrincipal InvestigatorNYU Langone Health

Media Library

Colchicine (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT03913442 — Phase 4
Osteoarthritis Research Study Groups: Placebo, Colchicine
Osteoarthritis Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT03913442 — Phase 4
Colchicine (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913442 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement for this research study restricted to persons under 45?

"The cut-off age for this clinical trial is 99 years, with all participants being of legal adult age or older."

Answered by AI

Does this research still have room for participants?

"As indicated on clinicaltrials.gov, the trial is presently recruiting participants and was first published in May 2019 with its most recent update occurring November 2022."

Answered by AI

To what extent have other research studies investigated the effectiveness of Colchicine 0.8 mg or 0.6 mg orally once daily?

"At this time, 31 clinical trials are researching the use of Colchicine 0.8 mg or 0.6 mg orally in daily intervals with 12 Phase 3 studies underway. Although many of these investigations occur around New york City, there exist a total of 98 sites where they can be found worldwide."

Answered by AI

What is the FDA-sanctioned dosage of orally administered Colchicine?

"Colchicine 0.8 mg or 0.6 mg taken orally once a day is rated 3 due to its Phase 4 status, which indicates it has been approved for public use."

Answered by AI

What is the purpose of administering Colchicine 0.8 mg or 0.6 mg orally once daily?

"Colchicine, a medication administered orally at 0.8 or 0.6 mg per day, is the most frequented treatment for gout flares and other ailments including familial mediterranean fever, postcommissurotomy syndrome, and behcet's syndrome."

Answered by AI

What is the enrollment capacity of this medical experiment?

"Indeed, the data hosted on clinicaltrials.gov indicates that this medical experiment is actively seeking participants since it was put online in May 15th 2019 and last updated on November 3rd 2022. As of now, a total of 120 individuals are required for trial at one single site."

Answered by AI

To what demographic of individuals is this research project best suited?

"This medical trial is recruiting 120 patients with arthrosis ranging from 18 to 99 years old. In order to apply, the patient must have a BMI of 32 or lower at enrollment, consent to be randomized between colchicine and placebo for three months, and be 40 years or older."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Arizona
How old are they?
65+
18 - 65
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Colchicine for the Treatment of Osteoarthritis of the Knee
2019. "Colchicine for the Treatment of Osteoarthritis of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913442.
~20 spots leftby Apr 2025
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