NCT04959851Completed
A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)
Prospective, Non-Interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes
Source: ClinicalTrials.gov · Last updated 6 Aug 2024
Brief summary (registry, in English)
IBD consists of either ulcerative colitis or Crohn's disease. The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include how vedolizumab is given, which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 185 (actual)
- First submitted
- 2 Jul 2021
- Start date
- 2 Dec 2021
- Primary completion date
- 18 Jun 2024
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04959851
What you commit to
- Study type: Observational
- Participants enrolled: 185
- From 2 Dec 2021 to the primary completion date, 18 Jun 2024
- 10 sites in 1 country
- 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, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
Other
- Current or planned participation in an interventional clinical trial for CD or UC.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 1\. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.
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 |
|---|---|---|---|
| UZA Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| GZA St. Vincentius Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| ZOL Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| AZ St. Lucas Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| CHR Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| CHU Liège Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| AZ Delta Coordinator of this site? Confirm its status | Roeselaere | Belgium | Unknown status |
| CHWAPI Coordinator of this site? Confirm its status | Tournai | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.