OsteoarthritisPhase 4CLOAKNCT03913442
Colchicine for the Treatment of Osteoarthritis of the Knee
A Phase 4 study testing Colchicine 0.8 mg or 0.6 mg orally once daily in people with Osteoarthritis and Osteo Arthritis Knee, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteoarthritis, Osteo Arthritis Knee
- What is being tested?
- Colchicine 0.8 mg or 0.6 mg orally once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 11 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Osteoarthritis, Osteo Arthritis Knee
- Being tested
- Colchicine 0.8 mg or 0.6 mg orally once daily, Placebo oral capsule
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.8 mg or 0.6 mg orally once dailyDrug
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)
Placebo oral capsuleDrug
Placebo 0.8 mg or 0.6 mg orally once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo in capsule identical to study drug Receives: Drug: Placebo oral capsule |
| Colchicine | Experimental | 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. Receives: Drug: Colchicine 0.8 mg or 0.6 mg orally once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Pain Score
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Baseline, 3 Months
Secondary outcomes (15)
Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The KOOS Pain Score refers to a specific subscale within the KOOS questionnaire that measures the severity of knee pain experienced by a patient, consisting of nine questions where each response is scored on a scale from 0 (no pain) to 4 (extreme pain), with a higher score indicating greater pain intensity; the overall pain score is then calculated as a percentage of the maximum possible score, where 0 represents the worst possible pain and 100 represents no pain at all.
Measured: Baseline, 3 Months
Change in the KOOS Stiffness Score
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). Each item on the KOOS is scored on a scale from 0 (no problems) to 4 (extreme problems), and then the scores are calculated to generate a final score between 0 and 100. The KOOS stiffness score is a percentage from 0 to 100 that measures how much stiffness a patient experiences in their knee. A score of 0 indicates the most stiffness, while a score of 100 indicates no stiffness.
Measured: Baseline, 3 Months
Change in the KOOS Physical Function Score
The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Physical Function items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems. The scores for each dimension are then transformed to a scale from 0 to 100, where 0 represents extreme problems with knee function and 100 indicates no problems at all.
Measured: Baseline, 3 Months
Change in the KOOS Quality of Life Score
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). A KOOS Quality of Life score ranges from 0 to 100, where 0 represents the worst possible knee-related quality of life and 100 indicates no problems at all. A higher score indicates better quality of life related to the knee.
Measured: Baseline, 3 Months
Change in the KOOS Sports and Recreational Activities
The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Sports and Recreational Activities 9 items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems relating to sports and recreational activities. The scores are then transformed to a scale from 0 to 100, with 100 indicating no knee problems with sports and recreational activities and 0 indicating extreme knee problems with sports and recreational activities .
Measured: Baseline, 3 Months
Change in the KOOS Total Score
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Measured: Baseline, 3 Months
Number of Participants Who Used Acetaminophen or Other Medications for Pain
Measured: 6 weeks
Number of Participants Who Used Acetaminophen or Other Medications for Pain
Measured: 3 Months
Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain
Measured: 6 weeks, 3 months
Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra)
Measured: Baseline, 3 months
Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2)
Measured: Baseline, 3 months
Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion
Size of effusion is measured as millimeters
Measured: Baseline, 3 months
Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US
Measured: Baseline, 3 months
Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP)
Measured: Baseline, 3 months
Change in Inflammatory Plasma Marker: Uric Acid
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start15 May 2019
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Pillinger, MD, FACP, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913442
- Sponsor's protocol ID
- 16-01796
- Acronym
- CLOAK
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2019
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Samuels J, Tse K, Wei D, Oh C, Bomfim F, Vieira RR, Leung N, Krasnokutsky-Samuels S, Toprover M, Attur M, Pillinger MH. CoLchicine for Treatment of OsteoArthritis of the Knee (CLOAK): Clinical and biochemical outcomes from a three-month double-blind, placebo-controlled study. Semin Arthritis Rheum. 2026 Aug 23;80:153066. doi: 10.1016/j.semarthrit.2026.153066. Online ahead of print.
PubMed 42679472
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03913442
- Acronym / sponsor ID
- CLOAK / 16-01796
- Conditions
- Osteoarthritis, Osteo Arthritis Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo in capsule identical to study drug |
| Colchicine | Experimental | Drug: Colchicine 0.8 mg or 0.6 mg orally once daily0.6 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.8 mg or 0.6 mg orally once dailyColchicine 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) | Drug | Colchicine |
| Placebo oral capsulePlacebo 0.8 mg or 0.6 mg orally once daily for 3 months | Drug | Placebo |
Primary outcome
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, 3 Months
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
15 secondary outcomes
Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
Time frame: Baseline, 3 Months
Change in the KOOS Stiffness Score
Time frame: Baseline, 3 Months
Change in the KOOS Physical Function Score
Time frame: Baseline, 3 Months
Change in the KOOS Quality of Life Score
Time frame: Baseline, 3 Months
Change in the KOOS Sports and Recreational Activities
Time frame: Baseline, 3 Months
Change in the KOOS Total Score
Time frame: Baseline, 3 Months
Number of Participants Who Used Acetaminophen or Other Medications for Pain
Time frame: 6 weeks
Number of Participants Who Used Acetaminophen or Other Medications for Pain
Time frame: 3 Months
Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain
Time frame: 6 weeks, 3 months
Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra)
Time frame: Baseline, 3 months
Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2)
Time frame: Baseline, 3 months
Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion
Time frame: Baseline, 3 months
Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US
Time frame: Baseline, 3 months
Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP)
Time frame: Baseline, 3 months
Change in Inflammatory Plasma Marker: Uric Acid
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42679472Samuels J, Tse K, Wei D, Oh C, Bomfim F, Vieira RR, Leung N, Krasnokutsky-Samuels S, Toprover M, Attur M, Pillinger MH. CoLchicine for Treatment of OsteoArthritis of the Knee (CLOAK): Clinical and biochemical outcomes from a three-month double-blind, placebo-controlled study. Semin Arthritis Rheum. 2026 Aug 23;80:153066. doi: 10.1016/j.semarthrit.2026.153066. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Pillinger, MD, FACP principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine 0.8 mg or 0.6 mg orally once daily in people with Osteoarthritis and Osteo Arthritis Knee, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Pain Score (time frame: Baseline, 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.