Clinical trial NCT04601883: Colchicine as Treatment for People With Hand Osteoarthritis
Official title: Colchicine Treatment for Patients With Hand Osteoarthritis: A Randomised, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis Hand
Osteoarthritis Finger
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion 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).

Exclusion Criteria:

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. Pregnancy.
28. 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.
29. 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.
30. 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).
31. 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.

1. The hand with most overall pain, assessed by VAS finger joint pain.
2. The hand with most overall reduced function, assessed by AUSCAN function subscale.
3. The hand with most overall stiffness, assessed by AUSCAN stiffness subscale.
4. The hand with most swollen joints, assessed by physician joint count.
5. The hand with most tender joints, assessed by physician joint count.
6. The hand with highest summed radiographic score, assessed by radiographic scoring of conventional X-ray.
7. If unable to select target hand based on the above criteria, a target hand will be randomly assigned.

Primary outcomes:
measure: Finger pain
timeFrame: Week 12
Secondary outcomes:
measure: Function
timeFrame: Week 12
measure: Thumb base pain
timeFrame: Week 12
measure: Pain hands
timeFrame: Week 12
measure: Joint activity
timeFrame: Week 12
measure: Patient global assessment
timeFrame: Week 12
measure: Quality of life measured by European Quality of Life 5 Dimensions
timeFrame: Week 12
measure: Hand strength
timeFrame: Week 12
measure: Number of treatment responders according to OMERACT-OARSI response criteria
timeFrame: Week 12
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Bispebjerg and Frederiksberg Hospital
state: DK
Study officials:
References: