Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout

Study Overview
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Brief Summary
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The purpose of this study is to compare the incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.

Detailed Description
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A prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. The incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat treatment.

Official Title
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Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Patients With Gout and Hyperuricemia During the Initial Phase of Urate-lowering Therapy: an Open-label Randomized Controlled Trial

Conditions
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Gout

Intervention / Treatment
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* Drug: Stepwise dose titration of febuxostat and low-dose colchicine
* Drug: Fixed dose febuxostat and low-dose colchicine


Participation Criteria
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Eligibility Criteria
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Ages Eligible for Study: more than 20 years Inclusion Criteria: Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria Acute gout attack during the last 12 months Exclusion Criteria: Acute gout attack in the last 2 weeks Urate-lowering therapy in the last 4 weeks Secondary hyperuricemia Creatinine ≥2.0 mg/dL AST or ALT ≥2x upper limits of normal Heart failure (NYHA III-IV) Hypersensitivity to colchicine, NSAID or febuxostat Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate Inability to comply with the protocol requirements The judgement of the investigator that the patient was not an appropriate candidate

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose titration group<br>Stepwise dose titration of febuxostat and low-dose colchicine | Drug: Stepwise dose titration of febuxostat and low-dose colchicine<br>* Febuxostat 10 mg, orally, once daily, in week 1-4 Febuxostat 20 mg, orally, once daily, in week 5-8 Febuxostat 40 mg, orally, once daily, in week 9-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12<br>|
| Active Comparator: Standard treatment group<br>Fixed dose febuxostat and low-dose colchicine | Drug: Fixed dose febuxostat and low-dose colchicine<br>* Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of gout flare during the first 12 weeks. | The percentage of the patients suffered from gout flare during the first 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of gout flares per patient during the first 12 weeks | The number of gout flares per patient during the first 12 weeks | 12 weeks | 
| The number of gout flares per patient during the second 12 weeks | The number of gout flares per patient during the second 12 weeks | 12 weeks | 
| The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks | The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks | 12, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine