Apremilast Therapy for Acute Gouty Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
WITHDRAWN
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
研究组 & 干预措施
indomethacin
Medication currently used for the treatment of acute gout
干预措施: indomethacin SR (Drug)
apremilast
Experimental treatment for acute gout
干预措施: apremilast (Drug)
结局指标
主要结局
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.
时间窗: Day 1, Day 7 and Day 21.
次要结局
- 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)