NL-OMON52963已完成2 期
Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Subject has a history of ileal pouch anal anastomosis (IPAA) for UC, all
- •stages completed at least 6 months prior to day one of the start of the study.
- •2. Subject has chronic, recurrent and/or antibiotic refractory pouchitis,
- •defined as a PDAI >= 7 (or mPDAI >= 5 if histology is pending) , with either
- •- >= 2 recurrent pouchitis episodes within 1 year prior to screening,
- •necessitating treatment with antibiotics or other prescription, or;
- •- Requiring maintenance antibiotic therapy for >= 4 weeks to maintain clinical
- •remission and a history of at least two attempts in the last 24 months to stop
- •this therapy, resulting in a relapse of the pouchitis episodes.
排除标准
- •1. Pouchitis due to surgery related conditions (such as an abscess, fistula, or
- •sinus of the pouch).
- •2. Absence of a previous pelvic MRI to assess secondary causes of pouchitis.
- •3. Irritable pouch syndrome (symptoms without evidence of pouchitis on
- •endoscopy and histology).
- •4. Mechanical complications of the pouch (e.g. pouch stricture or pouch
- •5. Diverting ileostomy.
- •6. Positive stool sample for C. difficile, enteric pathogens, pathogenic ova or
- •parasites at screening.
- •7. Active herpes zoster infection or history of disseminated zoster infection.
- •8. Evidence of an active infection during screening, or known history of
- •chronic HBV, HCV, HIV infection, or if subject is immunodeficient.
- •9. Active or latent infection with Mycobacterium tuberculosis (TB), regardless
- •of treatment history.
研究者
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