Osteoarthritis, KneePhase 3ECHONCT06578182
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
A Phase 3 study testing Colchicine in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,410 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to 31 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of knee or hip OA
- 45 ≤ age ≤ 80 (upper age limit is similar to that in the LoDoCo2 trial and takes in consideration the lower number of joint replacements in people older than 80 years)
- documented radiographic changes typical for advanced knee/hip OA (Kellgren \& Lawrence score ≥ 2), or at least 2-year history of complaints due to OA in the hip and/or knee
Who cannot join
- On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
- Any absolute contraindication for knee or hip replacement in the future
- More than one previous hip or knee replacements
- Other known medical disease that may affect joints
- Known generalized pain syndromes such as fibromyalgia
- Renal impairment as evidenced by serum creatinine >150µmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2
Show all 18Show fewer
- Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (upper limit of normal)
- Blood dyscrasia
- High frailty (clinical frailty scale ≥ 7) or predicted life expectancy < 5 years
- Peripheral neuritis, myositis or marked myo-sensitivity to statins
- Current use of colchicine for another indication
- Intolerance to colchicine
- use of macrolide antibiotics (i.e. clarithromycin, erythromycin, azithromycin), antimycotics (i.e. ketoconazole, itraconazole and voriconazole), protease inhibitors \& anti-retroviral drugs (i.e. ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat), anti-arrhythmic drugs (i.e. verapamil, diltiazem), or immunosuppressant (i.e. cyclosporine)
- Current enrollment in another trial
- Incapacitated patients
- Pregnant or breastfeeding female
- Fertile female participants not taking sufficient anti-conception
- Male participants unwilling to use effective contraception during the study to prevent pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Sint Maartenskliniek
Nijmegen
Tim Massa
About this study
Official title: The Effect of ColcHicine on the Incidence of Knee or Hip Replacements: a Randomized, Double-blind, Multicentre Study in Symptomatic Knee or Hip Osteoarthritis
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?
Read more
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:
- take colchicine every day for 3 tot 4.5 years
- visit the clinic every year for check-up and tests such as blood samples and x-rays
- fill in questionnaires every 3 months
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Colchicine, Placebo
- Keywords
- Colchicine, Knee replacement, Hip replacement
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 0.5mg tablets once a day for 3 to 4.5 years
PlaceboDrug
Placebo tablets once a day for 3 to 4.5 years
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Not described Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first knee or hip replacement
Measured: 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
Secondary outcomes (11)
Course of pain as assessed by NRS (numeric rating scale)
The 11-point NRS ranges from '0' ("no pain") to '10' ("worst pain imaginable")
Measured: 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 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Jan 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, RSMK, Tiofarma, Dutch Arthritis Foundation Reuma Nederland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578182
- Sponsor's protocol ID
- SMaartenskliniek
- Other IDs
- 10140262210012, 2024-511359-16-00
- Acronym
- ECHO
- Status last verified
- Dec 2024
- First submitted
- 4 Jul 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40228852
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ColcHicine on the Incidence of Knee or Hip Replacements: a Randomized, Double-blind, Multicentre Study in Symptomatic Knee or Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT06578182
- Acronym / sponsor ID
- ECHO / SMaartenskliniek
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Colchicine, Knee replacement, Hip replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,410 participants (estimated)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, RSMK, Tiofarma, Dutch Arthritis Foundation Reuma Nederland
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- take colchicine every day for 3 tot 4.5 years
- visit the clinic every year for check-up and tests such as blood samples and x-rays
- fill in questionnaires every 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of knee or hip OA
- 45 ≤ age ≤ 80 (upper age limit is similar to that in the LoDoCo2 trial and takes in consideration the lower number of joint replacements in people older than 80 years)
- documented radiographic changes typical for advanced knee/hip OA (Kellgren \& Lawrence score ≥ 2), or at least 2-year history of complaints due to OA in the hip and/or knee
Key exclusion criteria (18 listed)
- On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
- Any absolute contraindication for knee or hip replacement in the future
- More than one previous hip or knee replacements
- Other known medical disease that may affect joints
- Known generalized pain syndromes such as fibromyalgia
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 |
|---|---|---|
| ColchicineColchicine 0.5mg tablets once a day for 3 to 4.5 years | Drug | Colchicine |
| PlaceboPlacebo tablets once a day for 3 to 4.5 years | Drug | Placebo |
Primary outcome
Time to first knee or hip replacement
Time frame: 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
11 secondary outcomes
Course of pain as assessed by NRS (numeric rating scale)
Time frame: 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 pain as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 40228852Heijman 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.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Sint Maartenskliniek at 1 site in Netherlands.
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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 20 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Massa (+31633036353, t.massa@maartenskliniek.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first knee or hip replacement (time frame: 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). 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 NCT06578182, 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 20 Feb 2025.