NCT05192863Completed
A Study of Vedolizumab in Adults With Crohn's Disease (CD)
Complete Remission in Patients With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab - A Multicenter, Prospective Observational Cohort Study in Canada, Italy, and Israel
Source: ClinicalTrials.gov · Last updated 13 Nov 2025
Brief summary (registry, in English)
The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 72 (actual)
- First submitted
- 11 Jan 2022
- Start date
- 20 Mar 2023
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease
- NCT number
- NCT05192863
What you commit to
- Study type: Observational
- Participants enrolled: 72
- From 20 Mar 2023 to the primary completion date, 31 Oct 2025
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
- Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
Other illness
- Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
Other
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Ongoing or planned pregnancy or breastfeeding participants.
- Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
- Characteristics precluding IUS visualization of affected bowel segments or normal BWT of \<=3 mm for all segments.
Who the study is looking for
- Has moderately to severely active CD with a BWT of \>3 mm, based on IUS performed within the previous 4 weeks from baseline.
- Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Saskatchewan Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Fondazione Ca' Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| A. O. U. Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale ASST Rhodense Coordinator of this site? Confirm its status | Rho | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.