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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo in capsule identical to study drug |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.8 mg or 0.6 mg orally once daily | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Pillinger, MD, FACP | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months |
| FG001 | Colchicine | 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. Colchicine 0.8 mg or 0.6 mg orally once daily: 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months |
| BG001 | Colchicine | 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. Colchicine 0.8 mg or 0.6 mg orally once daily: 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose stools | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael H Pillinger, MD, FACP | NYU Langone Health | 646-501-2722 | Michael.Pillinger@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2023 | Jan 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo oral capsule | Drug | Placebo 0.8 mg or 0.6 mg orally once daily for 3 months |
|
| 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. | 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. | 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. | 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 . | 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. | Baseline, 3 Months |
| Number of Participants Who Used Acetaminophen or Other Medications for Pain | 6 weeks |
| Number of Participants Who Used Acetaminophen or Other Medications for Pain | 3 Months |
| Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain | 6 weeks, 3 months |
| Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra) | Baseline, 3 months |
| Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2) | Baseline, 3 months |
| Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion | Size of effusion is measured as millimeters | Baseline, 3 months |
| Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US | Baseline, 3 months |
| Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP) | Baseline, 3 months |
| Change in Inflammatory Plasma Marker: Uric Acid | Baseline, 3 months |
| Terminations |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months |
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|
| Secondary | 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 . | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months |
|
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|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months |
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| Secondary | Number of Participants Who Used Acetaminophen or Other Medications for Pain | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Participants Who Used Acetaminophen or Other Medications for Pain | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain | Posted | Number | participants | 6 weeks, 3 months |
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| Secondary | Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra) | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3 months |
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| Secondary | Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2) | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3 months |
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| Secondary | Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion | Size of effusion is measured as millimeters | In lieu of synovitis whose measurements proved difficult, the team relied on MSK-US-measured effusions. Only 28 and 19 participants effusion data were collected for the placebo and colchicine group, respectively. | Posted | Mean | Standard Deviation | millimeter | Baseline, 3 months |
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| Secondary | Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3 months |
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| Secondary | Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP) | Posted | Mean | Standard Deviation | mg/L | Baseline, 3 months |
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| Secondary | Change in Inflammatory Plasma Marker: Uric Acid | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3 months |
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|
| 0 |
| 51 |
| 0 |
| 51 |
| 34 |
| 51 |
| EG001 | Colchicine | 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. Colchicine 0.8 mg or 0.6 mg orally once daily: 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) | 0 | 49 | 0 | 49 | 36 | 49 |
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea/ Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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