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Keep this study
Lead
Takeda
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
1. 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.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
