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| ID | Type | Description | Link |
|---|---|---|---|
| 10140262210012 | Other Grant/Funding Number | ZonMW | |
| 2024-511359-16-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| RSMK | UNKNOWN |
| Tiofarma | UNKNOWN |
| Dutch Arthritis Foundation Reuma Nederland |
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The goal of this clinical trial is to evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on the incidence of first occurrence of knee or hip replacement. The main question it aims to answer is:
Does colchicine lower the number of knee or hip replacements in participants with osteoarthritis?
Researchers will compare colchicine to a placebo (a look-alike substance that contains no drug) to see if colchicine works to treat osteoarthritis.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 0.5mg tablets once a day for 3 to 4.5 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first knee or hip replacement | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Course of pain as assessed by NRS (numeric rating scale) | The 11-point NRS ranges from '0' ("no pain") to '10' ("worst pain imaginable") | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The number of (serious) adverse events | Adverse events are defined as any untoward medical occurrence in a subject to whom a medicinal product is administered, and which does not necessarily have a causal relationship with this treatment. Serious adverse event is any untoward medical occurrence in a patient or trial subject that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Massa | Contact | +31633036353 | t.massa@maartenskliniek.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Maartenskliniek | Recruiting | Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40228852 | Derived | Heijman MWJ, van den Ende CHM, Cornel JH, Smolders JMH, Schers HJ, Kievit W, Koeter S, van den Bemt BJF, Popa CD. Design of a randomised, placebo-controlled, double-blind multicentre study assessing the effect of colchicine on the incidence of knee or hip replacements in symptomatic knee or hip osteoarthritis: the ECHO trial. BMJ Open. 2025 Apr 14;15(4):e098096. doi: 10.1136/bmjopen-2024-098096. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| UNKNOWN |
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| Placebo |
| Drug |
Placebo tablets once a day for 3 to 4.5 years |
|
| Course of pain as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index) |
5 items are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores indicate more pain |
| From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Course of physical function as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index) | 17 items are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores indicate more functional limitations | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Course of joint space narrowing on X-ray | From baseline until the date of first documented knee or hip replacement or study end, whichever comes first, assessed up to 4.5 years |
| Course of low-grade inflammation as assessed by hs-CRP | At enrolment, at baseline, 1 year thereafter, and at study completion (approximately 4.5 years) |
| Course of quality of life as assessed by EQ-5D-5L (European Quality of Life 5 Dimensions) | The EQ-5D-5L comprises 5 dimensions with each dimension having 5 response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), unable to/extreme problems (5). EQ-5D-5L health states can be represented by a single summary number (index value) (range -0.624 to 1.000). Higher scores equals better quality of life | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Number of participants with clinical or radiological onset of OA in new joint group other than present at baseline over the trial period | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Time to clinical or radiological onset of OA in new joint group other than present at baseline over the trial period | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Number of participants using pain medication during the study registered per drug type (e.g. paracetamol, NSAIDs, opioids) | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Onset of new cardiovascular events, defined as myocardial infarction, peripheral artery disease, ischemia-driven coronary revascularization, ischemic stroke, or cardiovascular death | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Direct and indirect costs related to treatment and disease burden due osteoarthritis | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| The number of withdrawals due to (serious) adverse events | Adverse events are defined as any untoward medical occurrence in a subject to whom a medicinal product is administered, and which does not necessarily have a causal relationship with this treatment. Serious adverse event is any untoward medical occurrence in a patient or trial subject that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect | From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years |
| Changes in laboratory data (i.e. serum creatinine, estimated glomerular filtration rate, and alanine transferase) | At enrolment, at baseline, 1 year thereafter, and at study completion (approximately 4.5 years) |
| D012216 |
| Rheumatic Diseases |