VedolizumabSC-4004
Recruitment Complete
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland
Clinicaltrials.gov
#NCT05384080About this clinical trial
The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab induction and maintenance treatment for IBD [including Ulcerative Colitis (UC) and Crohn's Disease (CD)].
PL
Observational clinical trial.
At a glance
What medical conditions were being studied?
Ulcerative Colitis
Crohn's Disease
Inflammatory Bowel Disease (IBD)
How many participants were enrolled?
165
Were placebos part of the clinical trial?
No
When was the clinical trial conducted?
Aug 2022 - Aug 2025
How long was participation in the clinical trial?
Each participant will be in this study for 24 months.
Key requirements
Sex
All
Age
18+ years
Healthy volunteers?
No
Entry criteria
Data was collected from current patient records meeting the following criteria:
Must be 18 years of age or older
Must have moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab, or, IBD patients receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment
Cannot have 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
Cannot have current or planned participation in an interventional clinical trial for CD or UC
Additional entry criteria will be discussed with the study doctor.
