Gout Musculoskeletal Diseases Gout
Conditions
Interventions
Participants will be randomised to one of two interventions. Randomisation: 1:1 individual randomisation stratified by region and prior intolerance to Colchicine.
Intervention arm 1: Allopurinol-base
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Ability to give informed consent 3. Meets the clinical American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for gout 4. =1 flare of gout in the previous 12 months 5. Serum urate =360 µmol/L regardless of current ULT
Exclusion criteria
Exclusion criteria: 1. Previous allopurinol side-effects that contraindicate its prescription 2. Dementia, severe enduring mental illness i.e. mental health illness that makes receiving the study information and initial screening questionnaire from GP a stressful experience 3. Unable to comply with study procedures 4. Life expectancy less than 12 months 5. Cancer treatment, i.e. surgery, radiotherapy, or chemotherapy in the previous 12 months 6. Solid organ transplant 7. Cirrhosis 8. Autoimmune rheumatic disease i.e. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, connective tissue diseases, vasculitis, giant cell arteritis, polymyalgia rheumatica, inflammatory arthritis associated with inflammatory bowel disease, reactive arthritis, ankylosing spondylitis 9. Inflammatory bowel disease 10. Current long-term daily oral corticosteroid treatment defined as continuous use for =30 days or current immunosuppressive treatments 11. Stage 4/5 CKD i.e. eGFR < 30 ml/min 12. Pregnant, breastfeeding or planning to become pregnant in the next 4 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of gout flares in the first 2 years measured by patient initiated SMS service or acute gout flare diary | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of gout flares in months 1-12, measured by self-report using SMS or gout flare diary 2. Number of gout flares in months 13-24, measured by self-report using SMS or gout flare diary 3. Tophus count, measured by visual inspection at baseline, year 1 and year 2 4. Size of largest tophus, measured using vernier calipers at baseline, year 1 and year 2 5. Daily pain score measured by self-report using SMS or gout flare diary during gout flare 6. Quality of life measured by EQ-5D-5L during gout flares 7. GIS after flare resolution, measured by completing a questionnaire at baseline, year 1 and year 2 and during gout flares 8. Serum urate: proportion hitting the target serum urate level (<360 µmol/L) and continuous variable at year 1 and 2, measured from a blood sample taken at baseline and year 1 and year 2 post randomisation research visits 9. Quality of life measured by EQ-5D-5L between gout flares at baseline, year 1 and year 2 10. ULT (name and dose) measured by self-report during treatment visits and at year 1 and year 2 11. Treatment satisfaction measured by TSQM-II at year 1 and year 2 post randomisation 12. Returned pill count documented on a CRF at research year 1 and year 2 post randomisation visits 13. Compliance with ULT measured by MMAS-8 scale at year 1 and year 2 14. Serum creatinine and estimated GFR measured from a blood test at screening, year 1 and year 2 and during treatment visits in the intervention arm 15. Urine albumin-creatinine ratio measured from a urine sample at baseline, year 1 and year 2 16. Primary-care consultations for gout, measured by self-report and general practice record search at year 4 17. Hospitalizations due to gout, measured by self-report and general practice record search at year 4 18. Other prescriptions for treating flares of gout, measured by general practice record search at year 4 19. Investigations for gout, measured by general practice record search at year 4 20. Incident cardiovascular diseases, hypertension, | — |
Countries
England, United Kingdom
Contacts
Public ContactSteff Garvin
Outcome results
None listed