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The study aims to compare oral colchicine 0.5 mg administered two times daily for 12 weeks with placebo as a treatment of hand OA symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | Tablet colchicine 0.5 mg administered two times daily |
|
| Placebo | Placebo Comparator | Tablet placebo administered two times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG | Drug | The intervention tablets are commercially available Colchicine "Tiofarma" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Finger pain | To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, on changes in finger joint pain of the target hand from baseline to week 12, in patients with painful hand OA measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Function | To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in function of both hands measured on the Australian/Canadian Hand Index Function Score spanning from 0 to 900, where higher scores equals worse function. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Comorbidities
Other known medical disease that may affect joints, e.g. RA, gout, PsA
Positive anti-cyclic citrullinated peptide (>10 kU/L)
Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
Known blood dyscrasias and coagulation disorders
Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
Elevated alanine transaminase (>45 U/L females, >70 U/L for males)
Creatinine clearance ≤60 ml/min
Elevated creatine kinase (>210 U/L females, >280 U/L for males)
Known allergies towards the interventions
Drug or alcohol abuse in the last year
Generalised pain syndromes such as fibromyalgia
Current reflux
Current or recurrent diarrhoeal illnesses
Current abdominal pain
Known peripheral neuropathies
Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.
Medical history
History of hand surgery within 12 months prior enrolment.
History of arthroplasty or arthrodesis in the hand Management strategies
Treatment with P-glycoprotein inhibitors and/or cytochrome P450 3A4 (CYP3A4) inhibitors, see section "Colchicine safety in drug-drug interactions" and table 7. If potential participants have been treated with these pharmaceuticals previously, treatment must be terminated 5 half-lifes before initiation of study drug.
Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months.
Participation in experimental device or experimental drug study 3 months prior to enrolment.
Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
Intra-articular corticosteroids into any joint 1 months before inclusion
Current use of synthetic or non-synthetic opioids
Scheduled surgery during study participation
Planning to start other treatment for hand OA in the study participation period.
Reproductive system
Pregnancy.
Planned pregnancy within the study period, 3 months after end of study treatment for female fertile participant and 6 months after end of study treatment for male participant.
Insufficient anti-conception therapy for female fertile participants within the study period and 3 months after end of study treatment. Sufficient anti-conception therapy consists of intra-uterine device (coil),hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections) or sexual abstinence Female participants are considered infertile if they are postmenopausal or if they have undergone surgical sterilisation (bilateral salpingectomy, hysterectomy or bilateral oophorectomy). Postmenopausal state is defined as no menses for 12 months without alternative medical cause before inclusion in the study. Menopause state will be confirmed by measurement of follicle stimulating hormone.
Insufficient anti-conception therapy for male participants within the study period and 6 months after end of study treatment. Sufficient anti-conception therapy consists of condom or sexual abstinence. Male participants are considered sterile if they have undergone surgical sterilisation (vasectomy).
Breast-feeding
A target hand will be selected for outcome assessment once individual fulfills in- and exclusions criterias. Selection of the target hand will adhere to the following, with advancement to next step if unable to choose target hand based on the given criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute, Bispebjerg and Frederiksberg Hospital | Copenhagen | DK | 2500 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38251589 | Derived | Dossing A, Henriksen M, Ellegaard K, Nielsen SM, Stamp LK, Muller FC, Kloppenburg M, Haugen IK, McCarthy GM, Conaghan PG, Ulff-Moller Dahl L, Terslev L, Altman RD, Becce F, Ginnerup-Nielsen E, Jensen L, Boesen M, Christensen R, Dal U, Bliddal H. Colchicine twice a day for hand osteoarthritis (COLOR): a double-blind, randomised, placebo-controlled trial. Lancet Rheumatol. 2023 May;5(5):e254-e262. doi: 10.1016/S2665-9913(23)00065-6. Epub 2023 Apr 4. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2020 | Nov 14, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Encapsulated placebo tablets. Placebo is identical to the active intervention. |
|
| Thumb base pain |
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in thumb base pain of the target hand measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms. |
| Week 12 |
| Pain hands | To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in pain of both hands measured on the Australian/Canadian Hand Index Pain Score spanning from 0 to 500, where higher scores equals worse pain. | Week 12 |
| Joint activity | To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in joint activity of the target hand measured on physician tender joint count | Week 12 |
| Patient global assessment | To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in patient global assessment measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms. | Week 12 |
| Quality of life measured by European Quality of Life 5 Dimensions | To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in quality of life measured on the European Quality of Life 5 Dimensions spanning from -0.624 to 1.000, where higher scores equals better quality of life. | Week 12 |
| Hand strength | To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in hand strength of the target hand measured on grippit | Week 12 |
| Number of treatment responders according to OMERACT-OARSI response criteria | The following two conditions is observed at the post-baseline assessment:
| Week 12 |