drugset

drugset / Trial / NCT04089345

Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

NCT04089345 ↗

Phase 3 Completed 20 enrolled Universitaire Ziekenhuizen KU Leuven Janssen Pharmaceuticals · collab

NaSingle-groupOpen-labelTreatment

Summary

To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.

Timeline

Start: 2020-06-15
Primary completion: 2022-12-01
Completion: 2023-05-01

Publications

Outtier A, Louis E, Dewit O, Reenaers C, Schops G, Lenfant M, Pontus E, De Hertogh G, Verstockt B, Sabino J, Vermeire S, Ferrante M. Efficacy and Safety of Ustekinumab for Chronic Pouchitis: A Prospective Open-label Multicenter Study. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2468-2474.e1. doi: 10.1016/j.cgh.2024.04.030. Epub 2024 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ustekinumab	Monoclonal antibody	90 mg	Intravenous

Indications