Colchicine as treatment for persons with hand osteoarthritis

Phase 1

• Conditions: Hand osteoarthritis; MedDRA version: 21.1Level: LLTClassification code 10019115Term: Hand osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-002803-20-DK
• Lead Sponsor: Parker Instituttet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified