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 (the OCCUR trial)

Research question: What is the clinical and cost-effectiveness of oral prednisolone versus colchicine in people currently experiencing a gout flare who have relative contraindications to non-steroidal anti-inflammatory drugs (NSAIDs)?

Background: Gout is the most prevalent inflammatory arthritis, affecting 2.5% of adults in the UK, and causes significant pain, disability and impaired health-related quality of life. It is largely managed in primary care, where gout flares are most frequently treated with NSAIDs. However, relative contraindications to NSAIDs such as older age, chronic kidney disease or cardiovascular disease are prevalent in people with gout.

When gout flares occur in people with such contraindications, alternative treatments to NSAIDs, such as colchicine and corticosteroids, are needed. Objectives: to compare:

(1) the effectiveness of oral prednisolone and colchicine at reducing pain in adults with a gout flare and relative contraindications to NSAIDs;

(2) the effect of oral prednisolone and colchicine on time to resolution of pain, joint swelling and tenderness, adverse effects, physical function, quality of life, participant global assessment of treatment response, flare relapse/recurrence; sleep, use of walking aids, work/education absence, adherence and treatment satisfaction; and

(3) the cost-effectiveness of oral prednisolone and colchicine.

Methods: A multicentre pragmatic randomised open-label two-arm parallel group superiority trial with 12-month internal pilot and health economic evaluation. 280 adults aged =18-years with relative contraindications to NSAIDs and currently experiencing a gout flare will be recruited from up to 100 general practices across the UK. Participants will be randomised individually in a 1:1 ratio to oral prednisolone 30mg daily or colchicine 0.5mg three times daily (0.5mg twice daily if aged >70-years or known estimated glomerular filtration rate