Colchicine for the treatment of hip and knee osteoarthritis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Maartenskliniek

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

17 Jan 2025 → ongoing

Decision date (initial)

2024-11-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511359-16-00

WHO UTN

U1111-1307-2356

ClinicalTrials.gov

NCT06578182

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip OA on the incidence of first occurrence of knee or hip replacement.

Secondary objectives 9

1. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on pain
2. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on physical functioning
3. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on radiologic progression
4. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on low-grade inflammation
5. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on quality of life
6. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on new OA diagnosis
7. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on use of pain medication
8. To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on cardiovascular events
9. To evaluate the direct and indirect costs of colchicine related to treatment and disease burden due to osteoarthritis

Conditions and MedDRA coding

Osteoarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Clinical diagnosis of knee or hip OA
2. 45 ≤ age ≤ 80
3. 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 19

1. On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
2. Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (upper limit of normal)
3. Lowered blood cell counts: anaemia (haemoglobin <8.0 mmol/l in males or <7.0 mmol/l in females), leukopenia (< 3.5e9 leucocytes per litre), and/or thrombocytopenia (< 100e9 thrombocytes per litre)
4. High frailty (Clinical Frailty Scale ≥ 7) or predicted life expectancy < 5 years
5. 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), use of immunosuppressant (i.e. ciclosporine)
6. Intolerance to colchicine
7. Incapacitated patients
8. Pregnant or breastfeeding female
9. Fertile female participants not taking sufficient anti-conception
10. Male participants unwilling to use effective contraception during the study to prevent pregnancy
11. Peripheral neuritis, myositis or marked myo-sensitivity to statins
12. Current use of colchicine for another indication
13. Current enrollment in another trial
14. Any absolute contraindication for knee or hip replacement in the future
15. More than one previous hip or knee replacements
16. Other known medical disease that may affect joints
17. Known generalized pain syndromes such as fibromyalgia
18. Renal impairment as evidenced by serum creatinine >150µmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2
19. Inability to speak, read, or write in Dutch

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time from randomization to the first incident of TKR/THR

Secondary endpoints 10

1. Course of pain from randomization over the trial period
2. Course of physical function over the trial period
3. Radiological progression over the trial period
4. Change in low-grade inflammation at 1 year and end of the study
5. Course of quality of life over the trial period
6. Clinical or radiological onset of OA in new joint group other than hip and/or knee over the trial period
7. Use of pain medication during the study over the trial period
8. Onset of new cardiovascular events, defined as myocardial infarction, peripheral artery disease, ischemia-driven coronary revascularization, ischemic stroke, or cardiovascular death
9. Direct and indirect costs related to treatment and disease burden due osteoarthritis
10. Incidence and severity of adverse events throughout the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Maartenskliniek

Sponsor organisation

Sint Maartenskliniek

Address

Hengstdal 3

City

Ubbergen

Postcode

6574 NA

Country

Netherlands

Scientific contact point

Organisation

Sint Maartenskliniek

Contact name

Calin Popa

Public contact point

Organisation

Sint Maartenskliniek

Contact name

Calin Popa

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications