A pragmatic randomised trial comparing Oral Corticosteroids and Colchicine for the treatment of goUt flaRes in people with relative contraindications to non-steroidal anti-inflammatory drugs. (OCCUR)
Gout Flare
Participants will be randomised individually in a 1:1 ratio to oral prednisolone 30mg once daily (six 5mg tablets once daily) for five days or oral colchicine 0.5mg three times daily for four days (twice daily if aged≥70 years or known eGFR 15-29). Follow-up will be the same for both arms of the trial - twice daily during days 1-7, and at weeks 2, 3 and 4 in the form of questionnaires. Randomisation will be undertaken by authorised personnel (PI or a delegated person) via the CTU Clinical Data Management System (REDCap). This is a secure web-based data collection system that uses a randomisation module; the randomisation sequence will be computer-generated.
1. Aged ≥18 years 2. Current clinician-diagnosed gout flare 3. Fulfils Gaffo flare criteria, a validated definition of a gout flare requiring three out of four of: 3.1. Patient-defined flare (or clinician-defined flare if the patient had not had gout previously) 3.2. Pain score at rest of >3 on a 0–10 numeric rating score (NRS) 3.3. At least one swollen joint 3.4. At least one warm joint 4. Contraindication or caution to NSAIDs, defined as at least one of: 4.1. Age ≥65 years 4.2. Known estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m² 4.3. Prescribed anticoagulants 4.4. Allergy to aspirin or NSAID 4.5. Physician-diagnosed asthma 4.6. Physician-diagnosed peptic ulcer disease 4.7. Physician-diagnosed hypertension 4.8. Physician-diagnosed cardiovascular disease 4.9. Physician-diagnosed heart failure 4.10. Physician-diagnosed cerebrovascular disease
1. Known eGFR <15 ml/min/1.73m² or undergoing dialysis 2. Solid organ transplant recipients 3. Poorly controlled diabetes mellitus, defined as glycated haemoglobin (IFCC HbA1c) >64 mmol/mol 4. Current active infection 5. Known blood dyscrasias 6. Severe hepatic impairment 7. Previous intolerance of or hypersensitivity to prednisolone or colchicine (or excipients) 8. Taken prednisolone or colchicine for a gout flare in the previous 72 hours 9. Currently prescribed prednisolone for another indication 10. Currently prescribed verapamil, diltiazem, macrolides, HIV protease inhibitors, azole anti-fungals or ciclosporin 11. Known galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 12. Pregnancy or breastfeeding 13. Women of childbearing potential unless using effective contraceptive measures* 14. Unable or unwilling to provide informed consent 15. Has been randomised in the trial for a previous flare 16. Currently taking part in another gout CTIMP *Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.