Apremilast Therapy for Acute Gouty Arthritis

Study Overview
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Brief Summary
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The purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years. In order to learn about apremilast, half the participants in this study will receive apremilast and half the participants in this study will receive indomethacin. This study will measure the severity and duration of acute gout attacks in research participants, as well as measures of quality of life and any side effects or adverse reactions to the medication. There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate response to treatment with study medication at Day 7, and a follow-up visit at Day 21.

Detailed Description
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WITHDRAWN

Official Title
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Apremilast Therapy for Acute Gouty Arthritis

Conditions
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Acute Gout

Intervention / Treatment
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* Drug: apremilast
* Drug: indomethacin SR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must understand and voluntarily sign the informed consent Must have the diagnosis of gout proven by identification of urate crystals from body fluids Must be male age >18 years at the time of consent Must be able to adhere to the study visit schedule and other protocol requirements Must meet the following laboratory criteria: Hemoglobin > 9.0 g/dL White blood cell (WBC) count > 3000/μL and < 14,000/μL Platelet count >100,000/μL Serum creatinine < 2.0mg/dL Total bilirubin < 2.0 mg/dL Aspartate transaminase (AST) and alanine transaminase (ALT) <1.5 X upper limit of normal Males, including those who have had a vasectomy, must agree to use barrier contraception (latex condom) when engaging in sexual activity with a female of child-bearing potential (FCBP) while on study medications and for 84 days after taking the last does of the medication Exclusion Criteria: Inability to provide voluntary consent Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret the data from the study Females Systemic fungal infection History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment in the past 2 years An active infection at presentation Use of any investigational medication within 4 weeks prior to start of study or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer Any use of corticosteroids, cyclosporine, methotrexate, cyclophosphamide, azathioprine, mycophenolate within 4 weeks prior to start of study Any clinically significant abnormality on 12-lead ECG screening Malignancy or history of malignancy (except for treated and cured basal-cell skin carcinomas > 3 years prior to screening)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apremilast<br>Experimental treatment for acute gout | Drug: apremilast<br>* apremilast 20 mg taken twice daily by mouth<br>|
| Active Comparator: indomethacin<br>Medication currently used for the treatment of acute gout | Drug: indomethacin SR<br>* indomethacin SR 75 mg taken twice daily by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported number of swollen joints, the number of tender joints, the number of warm joints, as well as self-report pain, global assessment, and functional status. Subject-reported time to resolution of symptoms will be measured. |  | Day 1, Day 7 and Day 21. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (type, frequency, severity, and relationship of adverse events to apremilast, laboratory, ECG, physical exam or other changes) and tolerability |  | Day 1, Day 7 and Day 21. | 
| Quality of Life |  | Assessed at Day 1, Day 7 and Day 21 study visits | 

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