Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Crohn Disease
Believable
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 Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Official Title : | Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study |
| Actual Study Start Date : | February 15, 2023 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | June 1, 2024 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China,