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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.
- Osteoarthritis of the Knee
CLOAK Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
CLOAK Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2021 Phase 4 trial • 280 Patients • NCT01709981
Awards & Highlights
CLOAK Trial Design
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Who is running the clinical trial?
- You have been diagnosed with gout or other types of arthritis, such as rheumatoid arthritis, psoriatic arthritis, reactive arthritis, or spondyloarthropathy.You have been diagnosed with diabetes, a long-term infection, heart failure, or cancer (excluding skin cancer) in the last 5 years.You are scheduled to have a full knee replacement surgery in the next 3 months.You are still having frequent knee problems as previously described.The person must have a BMI of less than or equal to 32 at the time of enrollment.I agree to take either colchicine or a placebo every day for three months.
- Group 1: Placebo
- Group 2: Colchicine
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
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