Clinical trial: Colchicine as Treatment for People With Hand Osteoarthritis (NCT04601883)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? 1