Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT04959851
Brief Summary:
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).
Detailed Description:
This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab according to the current SmPC in the real world setting.
The study will enroll approximately 200 participants. The data will be collected prospectively and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
• Participants with IBD
This multi-center study will be conducted in Belgium at specialized gastroenterology centers.
Study:
NCT04959851
Study Brief:
Protocol Section:
NCT04959851