Allopurinol Outcome Study

Study Overview
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Brief Summary
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This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.

Official Title
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Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)

Conditions
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Gout

Intervention / Treatment
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* Drug: Allopurinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout. Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening. If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening. Must have had at least 2 gout flares in the past year. Exclusion Criteria: Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor). History or suspicion of drug abuse. History of autoimmune disease requiring systemic treatment. Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection. History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer). Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months. Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg). Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula. Kidney or other organ transplant. Active peptic ulcer disease requiring treatment. History of xanthinuria, active liver disease, or hepatic dysfunction. If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications). Known hypersensitivity or allergy to allopurinol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Allopurinol<br>Treatment. | Drug: Allopurinol<br>* Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Allopurinol | Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study. | Every month for 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL | Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6. | Month 6 | 
| Incidence of Gout Flares | Proportion of subjects who experienced at least one gout flare requiring treatment during the study. | Every month for 6 months. | 
| Mean Change From Baseline to Month 6 in SF-36 PCS+MCS | The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10. | Month 6 |