Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol

Study Overview
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Brief Summary
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The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.

Conditions
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Intercritical Gout

Intervention / Treatment
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* Drug: Colchicine (Colcrys®)
* Drug: placebo
* Drug: allopurinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria include, but are not limited to the following: Men and postmenopausal women between the ages of 18 and 70 Meets the ARA criteria for classification of acute gout Tophi present and/or a history of gout attacks in 2 or 3 joints Self-reported history of at least 2 gout flares in the prior 12 months Serum uric acid greater than or equal to 7.5 mg/dL at the first visit Exclusion Criteria: Exclusion criteria include, but are not limited to the following: Patients with an acute gout flare within 2 weeks prior to the first visit Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks Patients with more than three joints affected by gout History of intolerance or allergy to colchicine or allopurinol Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study Use of colchicine less than 14 days prior to entering the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: placebo<br>daily placebo dosing for 16 weeks with background allopurinol therapy | Drug: placebo<br>* daily placebo dosing for 16 weeks<br>Drug: allopurinol<br>* background therapy<br>|
| Active Comparator: Colchicine (Colcrys®)<br>daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy | Drug: Colchicine (Colcrys®)<br>* daily 0.6 mg colchicine dosing for 16 weeks<br>Drug: allopurinol<br>* background therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Gout Flares Per Participant From Day 1 to Week 16 |  | Day 1 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 |  | Day 1 to Week 16 | 
| Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 |  | Day 1 to Week 16 | 
| Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 |  | Day 1 to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout