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Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

Crohn Disease Clinical Trial

Official title:
Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study

Clinical Trial Summary

The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

Clinical Trial Description

This study evaluates the efficacy and safety of intravenous administration at regular intervals of Ustekinumab. It consists of escalation treatment period (Week 0 to 52); and safety follow up visit (24 weeks after last dose). Study assessments will include Harvey-Bradshaw index (HBI), Physician Global Assessment Score (PGA), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (AEs). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05705856
Study type Observational
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Yuting Wang, MD
Phone 18868102022
Email wangyuting22@126.com
Status Recruiting
Phase
Start date February 15, 2023
Completion date June 1, 2024
View Details
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