A Single Center Open-Label Prospective Study Of Oral Tofacitinib In Patients With Chronic Pouchitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Response/Remission
研究概览
简要总结
A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis
详细描述
The proposed study is a phase 2, open-label study of tofactinib in treatment of patients with chronic pouchitis. Subjects with chronic active pouchitis will be screened and recruited if they meet eligibility criteria. Eligible subjects will undergo baseline clinical evaluation, laboratory testing and a pouch endoscopy. They will then receive oral tofacitinib 10 mg twice daily for 8 weeks. Clinical and laboratory data will be collected at week 4 and week 8, and all subjects will undergo a end of treatment pouch endoscopy at 8 weeks. Clinical, laboratory and endoscopic data at 8 weeks will be compared to the baseline data to evaluate study outcomes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ages 18 to 80
- •Subjects with a history of proctocolectomy with ileal pouch anal anastomosis (IPAA) for UC at least 6 months prior to screening.
- •Subjects with pouchitis that is chronic, defined by a mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline study visit and a minimum endoscopic sub-score of 2 (outside the staple or suture line) with either (a) ≥ 3 recurrent episodes within 1 year prior to the screening treated with ≥2 weeks of antibiotic or other prescription therapy, (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline study visit
- •Women of childbearing potential must have documentation of a negative pregnancy test at screening and must agree to use two highly effective methods of birth control during the study and for at least 1 month after completion of study drug dosing.
排除标准
- •Subjects with IPAA surgery done for Crohn's disease (CD) or familial adenomatous polyposis (FAP) indications.
- •Subjects with primary CD of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch.
- •Subjects with prior exposure to tofacitinib.
- •Subjects with a diverting stoma.
- •Subjects with a prior history or risk factors for venous thromboembolism.
- •Subjects with active bacterial, parasitic, fungal, mycobacterial, or viral infection.
- •Subjects with a history of latent or active tuberculosis.
- •Subjects positive for hepatitis B virus (HBV) surface antigen, hepatitis B virus core antibody with a negative hepatitis B surface antibody or with detectable serum hepatitis B DNA.
- •Female subjects who are pregnant or lactating.
- •Female subjects of childbearing potential who are sexually active and do not agree to using two highly effective methods of contraception during the study period.
- •Subjects with clinically significant laboratory abnormalities at study screening.
- •Other eligibility criteria apply
研究组 & 干预措施
Chronic pouchitis
This arm will include subjects with chronic pouchitis and will receive tofactinib 10 mg twice daily for 8 weeks
干预措施: Tofacitinib 10 mg (Drug)
结局指标
主要结局
Number of Participants With Clinical Response/Remission
时间窗: 8 weeks
The proportion of subjects with clinical response at 8 weeks, defined as ≥2-point decrease in modified pouchitis disease activity index (mPDAI) with at least 1-point decrease in endoscopic subscore compared to the baseline.The mPDAI is a 0- 18 point scale of pouchitis disease severity, with higher scores corresponding to worse disease severity.
次要结局
- Number of Participants With Clinical Response(8 weeks)
- Number of Participants With Clinical Remission(8 weeks)
- Change in mPDAI Score(8 weeks)
- Change in mPDAI Clinical Sub-score(8 weeks)
- Change in IBD-related Quality of Life(8 weeks)
- Change in mPDAI Endoscopic Sub-score(8 weeks)
研究者
Gil Melmed
Professor of Medicine
Cedars-Sinai Medical Center