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NCT Number: NCT06578182

The Effect of ColcHicine on the Incidence of Knee or Hip Replacements

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sint Maartenskliniek

Nijmegen, Netherlands

Location status: Recruiting

Location contact

Tim Massa

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Colchicine

Drug

Colchicine 0.5mg tablets once a day for 3 to 4.5 years

Placebo

Drug

Placebo tablets once a day for 3 to 4.5 years

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    The 11-point NRS ranges from '0' ("no pain") to '10' ("worst pain imaginable")

  2. 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

    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

  3. 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

    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

  4. 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

  5. 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)

  6. 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

    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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Other outcomes

  1. The number of (serious) adverse events

    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

    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

  2. The number of withdrawals due to (serious) adverse events

    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

    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

  3. Changes in laboratory data (i.e. serum creatinine, estimated glomerular filtration rate, and alanine transferase)

    Time frame: At enrolment, at baseline, 1 year thereafter, and at study completion (approximately 4.5 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Tim Massa

CONTACT

[email protected]

+31633036353

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Collaborators

  • Dutch Arthritis Foundation Reuma Nederland
  • RSMK
  • Tiofarma
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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

Acronym: ECHO

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 29, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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