Tofacitinib For Treatment Of Chronic Pouchitis

Status Terminated

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

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04979832` - GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery	Phase 1/Phase 2
Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Not yet recruiting	`NCT05829109` - Fecal Microbiota Transplant for Patients With Chronic Pouchitis	Early Phase 1
Recruiting	`NCT03136419` - Microbiota and Immune microEnvironment in Pouchitis	N/A
Withdrawn	`NCT04640155` - Treating Chronic Pouchitis With a Low FODMAP Diet	N/A
Completed	`NCT02201186` - To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis	Phase 2
Completed	`NCT02790138` - A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis	Phase 4
Not yet recruiting	`NCT01202396` - The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis	N/A
Completed	`NCT02428361` - Fecal Microbiota Transplant (FMT) for Pouchitis	Early Phase 1
Completed	`NCT03538366` - Fecal Microbiota Transplantation for Chronic Pouchitis	N/A
Completed	`NCT04763564` - Efficacy of Liraglutide Therapy in Patients With IPAA	Phase 2
Terminated	`NCT00583531` - Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis	Phase 2
Recruiting	`NCT03524352` - the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis	Phase 3
Completed	`NCT04820413` - Faecal Microbiota Transplantation From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis	N/A
Not yet recruiting	`NCT06443502` - A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis	Phase 3
Recruiting	`NCT04089345` - Stelara fOr ChRonic AntibioTic rEfractory pouchitiS	Phase 3
Not yet recruiting	`NCT03526796` - Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis	N/A
Terminated	`NCT02782325` - Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)	Phase 1/Phase 2
Completed	`NCT02828410` - Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA	N/A
Recruiting	`NCT05578313` - Inflammatory Bowel Diseases (IBD) Cannabis Registry