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Clinical Trial Summary

A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04580277
Study type Interventional
Source Cedars-Sinai Medical Center
Contact
Status Terminated
Phase Phase 2
Start date January 25, 2021
Completion date May 15, 2023

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