Stelara fOr ChRonic AntibioTic rEfractory pouchitiS — SOCRATES  

Pouchitis Clinical Trial

Official title: Stelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES): A Belgian Open Label Multicenter Pilot-study

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

This study is a Belgian prospective open label multicenter study to evaluate the efficacy and safety of ustekinumab in the treatment of relapsing or chronic antibiotic refractory pouchitis during a 48-week treatment period. Twenty subjects with a RPC and IPAA for UC who have developed relapsing or chronic antibiotic refractory pouchitis will be enrolled. All patients will receive intravenously (IV) ustekinumab ~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through Week 4. Intravenous induction doses will be 260mg for patients <55kg, 390mg for patients between 55 and 85kg, and 520mg for patients with a body weight >85 kg. Clinical and biochemical evaluation will be planned every 8 weeks. Efficacy will be assessed at Week 16 and Week 48 using mPDAI and PDAI scores, therefor a pouchoscopy with biopsy sampling will be performed. Patients who do not achieve partial response (reduction of mPDAI score by ≥2 points from baseline) at Week 16 will be discontinued. ;

Related Conditions & MeSH terms

• Pouchitis

• NCT number: NCT04089345
• Study type: Interventional
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Ganel Schops
• Phone: +321648856
• Email: IBD_studies@uzleuven.be
• Status: Recruiting
• Phase: Phase 3
• Start date: June 11, 2020
• Completion date: May 2023