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

Phase 4

Completed

• Conditions: Intercritical Gout
• Interventions: Drug: placebo; Drug: Colchicine (Colcrys®); Drug: allopurinol

• Registration Number: NCT01451645
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-14
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Results First Submitted: 2013-09-24
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-07
• Last Update Submitted: 2014-04-07
• Results First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Inclusion criteria include, but are not limited to the following:

1. Men and postmenopausal women between the ages of 18 and 70
2. Meets the ARA criteria for classification of acute gout
3. Tophi present and/or a history of gout attacks in 2 or 3 joints
4. Self-reported history of at least 2 gout flares in the prior 12 months
5. 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:

1. Patients with an acute gout flare within 2 weeks prior to the first visit
2. Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks
3. Patients with more than three joints affected by gout
4. History of intolerance or allergy to colchicine or allopurinol
5. Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study
6. Use of colchicine less than 14 days prior to entering the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	daily placebo dosing for 16 weeks with background allopurinol therapy
Colchicine (Colcrys®)	Colchicine (Colcrys®)	daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
placebo	allopurinol	daily placebo dosing for 16 weeks with background allopurinol therapy
Colchicine (Colcrys®)	allopurinol	daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy

Primary Outcome Measures

Name	Time	Method
Number of Gout Flares Per Participant From Day 1 to Week 16	Day 1 to Week 16

Secondary Outcome Measures

Name	Time	Method
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