Hand osteoarthritis MedDRA version: 21.1 Level: LLT Classification code 10019115 Term: Hand osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Colchicin
Pharmaceutical Form: Tablet
INN or Proposed INN: Colchicine
Other descriptive name: COLCHICINE PH. EUR.
Concentration unit: g gram(s)
Concentration type: equal
Concentration numb
Sponsors
Parker Instituttet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: An individual will be eligible for study participation if he/she meets the following criteria: 1. Age =18 years. 2. Hand OA according to the ACR criteria above. 3. Hand OA finger pain: Pain at rest =40 mm on VAS (0 to 100 mm range). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: A participant will be excluded from the study if he/she meets any of the following criteria listed below. Some exclusion criteria require a blood sample, please see section “Visit 2: Screening visit”. Known diseases will be based on diagnosis registered in the participants health journal. If an exclusion diagnose is suspected necessary diagnostics will be performed before inclusion in the study. Comorbidities 1. Other known medical disease that may affect joints, e.g. RA, gout, PsA 2. Positive anti-cyclic citrullinated peptide (>10 kU/L) 3. Known cutaneous deposition diseases (e.g. amyloidosis or porphyria). 4. Known blood dyscrasias and coagulation disorders 5. Known malignancy (except successfully treated squamous or basal cell skin carcinoma) 6. Elevated alanine transaminase (>45 U/L females, >70 U/L for males) 7. Creatinine clearance =60 ml/min 8. Elevated creatine kinase (>210 U/L females, >280 U/L for males) 9. Known allergies towards the interventions 10. Drug or alcohol abuse in the last year 11. Generalised pain syndromes such as fibromyalgia 12. Current reflux 13. Current or recurrent diarrhoeal illnesses 14. Current abdominal pain 15. Known peripheral neuropathies 16. 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 17. History of hand surgery within 12 months prior enrolment. 18. History of arthroplasty or arthrodesis in the hand Management strategies 19. 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. 20. Use of systemic corticosteroids equivalent of = 7.5 mg prednisolone daily within 3 months. 21. Participation in experimental device or experimental drug study 3 months prior to enrolment. 22. Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion 23. Intra-articular corticosteroids into any joint 1 months before inclusion 24. Current use of synthetic or non-synthetic opioids 25. Scheduled surgery during study participation 26. Planning to start other treatment for hand OA in the study participation period. Reproductive system 27. Planned pregnancy within the study period, pregnancy or insufficient anti-conception therapy for female fertile participants. Sufficient anti-conception therapy consists of intra-uterine device (coil) or hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections). 28. Breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, on changes in finger joint pain of the target hand measured on a visual analogue scale (VAS) from baseline to week 12, in patients with painful hand OA.;Secondary Objective: 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: o Function of both hands measured on the AUSCAN Hand Index Score o Thumb base pain of the target hand measured on a VAS scale o Pain of both hands measured on the Australian/Canadian (AUSCAN) Hand Index Score o Joint activity of the target hand measured on physician tender joint count o Patient global assessment measured on a VAS scale o Quality of life measured on the European Quality of Life 5 Dimensions (EQ-5D) o Hand strength of the target hand measured on grippit o Treatment response measured on the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria [27] at week 12, in patients with painful hand OA. ;Primary end point(s): Change from baseline in VAS finger joint pain of the target hand at week 12;Timepoint(s) of evaluation of this end point: 4 weeks of treatment and 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes are change from baseline to week 12 in: • Physical function of both hands assessed by AUSCAN physical function subscale • VAS thumb base pain of the target hand • Pain of both hands assessed by AUSCAN hand pain subscale • Joint activity of the target hand assessed by physician tender joint count in the target hand • VAS patient global assessment • Quality of life assessed by the EQ-5D • Hand strength of the target hand assessed by grippit • Fulfilment of OMERACT-OARSI responder criteria ;Timepoint(s) of evaluation of this end point: Joint activity and hand strength are only assessed at week 12 All other secondary end points are assessed at week 4 and week 12. | — |
Countries
Denmark
Contacts
Public ContactOsteoarthritis Outpatient Clinic
Parker Instituttet
Outcome results
None listed