A Pilot Study Evaluating the Efficacy of Apremilast in the Treatment of Subjects With Severe Recurrent Aphthous Stomatitis (RAS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Duration of RAS Lesions
研究概览
简要总结
Determination of treatment efficacy and safety of Apremilast in patients with RAS
详细描述
The study will be a pilot study using apremilast 30mg orally twice daily, for treatment of RAS in males and females between 18 and 70 years old.
Subjects will be recruited from the clinical practice of the Department of Dermatology or Division of Rheumatology at Mayo Clinic Florida. Fifteen males and females with RAS will be enrolled.
The study will consist of 3 phases: a screening phase, a 16 week treatment phase and an 8 week posttreatment observational follow-up phase.
The screening phase will consist of: obtaining informed consent, demographic information, medical history, inclusion and exclusion criteria, prior and concomitant medication use, adverse events; collecting vital signs and weight; performing complete physical examination and limited physical examination; obtaining hematology, serum chemistry, urinalysis, pregnancy test and providing contraception education.
During the 16-week treatment phase, all subjects receive apremilast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Apremilast 30mg orally twice daily for 16 weeks, sixteen weeks on active study. Post treatment follow-up period of 8 weeks, in the Treatment of Subjects with Severe Recurrent Aphthous Stomatitis (RAS)
干预措施: Apremilast 30mg (Drug)
结局指标
主要结局
Duration of RAS Lesions
时间窗: 24 weeks
The total length of time (duration) subjects experienced RAS lesions. Measured in weeks
Change in Number of RAS Lesions
时间窗: baseline, 24 weeks
Number of participants with fewer oral ulcers at Week 24 compared to Baseline
Duration of the Remission Period Between Ulcer Episodes
时间窗: 24 weeks
The length of time of remission of RAS lesions experienced by the subjects. As measured in months.
次要结局
- Adverse Events(24 weeks)
- Discontinuation of Study Participants(24 weeks)
- Change in Visual Analog Scale Pain Score (VAS) From Baseline to 16 Weeks and Baseline to 24 Weeks.(baseline, 16 weeks, 24 weeks)
研究者
Alison J. Bruce
Principle Investigator
Mayo Clinic