Colchicine prophylaxis in gout patients commencing urate lowering therapy

Not Applicable

Completed

• Conditions: Gout; Musculoskeletal - Other muscular and skeletal disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12618001179224
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-17
• Study Completion: 2023-01-16
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean number of gout flares per month measured using a study specific questionnaire and self reported flare requiring treatment.[Questionnaire completed monthly for 12 months post enrolment.];Adverse effects related to colchicine . Possible side effects relating to colchicine include skin rash, fever, diarrhoea, difficulty passing urine, muscle weakness or numbness, bleeding, and mouth ulcers. Adverse events will be recorded using a study specific questionnaire. [Questionnaire completed monthly for 6 months post enrolment.]