None listed
Conditions
Brief summary
This protocol describes a 12-month double blind placebo controlled randomised non-inferiority trial in people commencing allopurinol for gout. The study will recruit 200 people with gout commencing urate lowering therapy using start-low go-slow allopurinol dose escalation approach. Participants will be randomly assigned to prophylaxis with colchicine 0.5mg daily or placebo for six months followed by a further six months of follow-up. The primary efficacy endpoint will be difference in mean number of flares per month between 0 and 6 months between randomised groups. The primary safety outcome will be adverse events over the period of study treatment. Secondary endpoints will include difference in mean number of flares per month between 0 – 3 months and 6 - 12 months, percentage of patients with flare at each month, time to first flare, need for rescue therapy for gout flares, and cost effectiveness.
Interventions
The intervention is colchicine 0.5mg as an oral capsule daily for six months. Adherence will be monitored by a drug tablet return at three month and six month study visits. Colchicine and allopurinol will be commenced together at the baseline visit.
All participants will receive allopurinol regardless of randomisation.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*Gout according to the 2015 American College of Rheumatology and European League Against Rheumatism criteria Serum urate >0.36mmol/ *At least one self-reported gout flare in last 6 months *Fulfilling American College of Rheumatology criteria for urate lowering therapy with allopurinol (gout with greater than or equal to 2 flares in a year, tophi, chronic kidney disease greater than or equal to stage 2 (eGFR<90mls/min/1.73m2), or past kidney stones) *Agreeable to starting allopurinol *Ability to give informed consent *Ability to communicate via telephone
Exclusion criteria
*Contra-indication or previous intolerance to allopurinol *Contra-indication or previous intolerance to colchicine *Urate lowering therapy within 1 month of enrolment *Stage 4 or 5 chronic kidney disease *Concomitant azathioprine, cyclosporine, or other immunosuppression *Unstable co-morbid health conditions (e.g stage 4 heart failure, recent myocardial infarction, advanced cancer) *Dementia *Unable to comply with study procedures *Use of regular non steroidal anti inflammatory for other medical conditions.
Outcome results
None listed