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Colchicine for Osteoarthritis of the Knee(CLOAK Trial)

NYU Langone Health, New York, NY
Targeting 2 different conditionsColchicine 0.8 mg or 0.6 mg orally once daily +1 morePhase 4RecruitingLed by Michael H Pillinger, MD, FACPResearch Sponsored by NYU Langone Health

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.

Eligible Conditions
  • Osteoarthritis of the Knee
  • Osteoarthritis

CLOAK Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are still having frequent knee problems as previously described.

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
Chest pain
Ischemic stroke
Study treatment Arm

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,338 Previous Clinical Trials
795,312 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,009 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?
How old are they?
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
~10 spots leftby Jun 2024