NCT04580277

Tofacitinib For Treatment Of Chronic Pouchitis

A Single Center Open-Label Prospective Study Of Oral Tofacitinib In Patients With Chronic Pouchitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pouchitis
• Ileal Pouchitis
• Ileal Pouch

Interventions

Type	Name	Description
DRUG	Tofacitinib 10 mg	Subjects in this arm will receive tofactinib 10 mg twice daily for 8 weeks

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-12-01
• Completion: 2023-05-15
• First posted: 2020-10-08
• Last updated: 2024-04-04
• Results posted: 2024-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study