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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Intercritical Gout

Treatments: Drug: placebo; Drug: Colchicine (Colcrys®); Drug: allopurinol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01451645

IL1T-GA-1103

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

placebo

Other group

Description:

daily placebo dosing for 16 weeks with background allopurinol therapy

Treatment:

Drug: allopurinol

Drug: placebo

Colchicine (Colcrys®)

Active Comparator group

Description:

daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy

Treatment:

Drug: Colchicine (Colcrys®)

Drug: allopurinol