A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland

Launched by TAKEDA · May 17, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medication called Vedolizumab is being used to treat adults with Ulcerative Colitis (UC) or Crohn's Disease (CD) in Poland. The study is not testing a new treatment but is observing how patients currently receiving Vedolizumab, either through an intravenous (IV) method or a subcutaneous (SC) injection, are doing. Researchers want to gather information about the treatment patterns and outcomes for people with moderate to severe inflammatory bowel disease (IBD) who are starting or continuing this therapy.

To participate in the trial, individuals should have moderately to severely active UC or CD and be starting or already receiving Vedolizumab treatment. However, people with certain severe infections or those who have had bad reactions to Vedolizumab in the past cannot join the study. Participants won't be given any new treatments during this trial but will help researchers understand how Vedolizumab is working for others in real-world settings. It’s important to note that the trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.Participants with moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC and National Drug Program (NDP) at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.
• Exclusion Criteria:
• • 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.
• • .