A randomised trial of colchicine for osteoarthritis of the hand (COLAH)
- Conditions
- Hand OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12617001524381
- Lead Sponsor
- Dr Catherine Hill
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 61
1)Aged between 40 and 80 years old
2)Men and women with significant hand pain within the last 48 hours (defined as a VAS greater than or equal to 40 mm) with a history of Hand pain for minimum of 6 months.
3)Radiological OA (Kellgren and Lawrence (KL) grade > 1) in > 1 joint
4)Meet American College of Rheumatology (ACR) clinical criteria for hand OA
1.Concomitant inflammatory rheumatic disease
2.Contraindication to colchicine. This includes renal dysfunction (eGFR <50, abnormal LFT, haematologic condition
3.Chronic glucocorticoid, DMARD or immunosuppressant therapy for arthritis or other indications
4.Women who are pregnant or breast feeding
5.Use of any investigational drug(s) and/or devices within 30 days prior to randomisation
6.Presence of any serious medical illness that may preclude 24 week follow up.
7.Inability to provide informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS pain scores[0 weeks, 6 weeks, 12 weeks and 16 weeks ]
- Secondary Outcome Measures
Name Time Method AUSCAN score[0 weeks, 6 weeks, 12 weeks and 16 weeks];Ultrasound measured synovitis[0 weeks and 12 weeks];Adverse effects (measured by patient report, renal, haematological and hepatic function) [Week 6, Week 12 and Week 16];C-reactive protein (from blood samples) at week 0 and week 12[Week 12];Grip strength measured by dynamometer at week 0 and week 12. [Week 12];Number of tender joints of affected hand at week 0 and week 12[Week 12];Number of swollen joints at week 0 and week 12[Week 12]