Crohn Disease Clinical Trial
Official title:
Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life
The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.
This is a prospective, non-interventional and pharmaco-epidemiological study of participants
with IBD. The study will provide the real-life data of treatment effectiveness and safety of
vedolizumab in adult participants with UC or CD.
The study will enroll approximately 300 participants. All participants will be enrolled in
one observational group:
Vedolizumab
Data will be collected and observed for 24 months in the participants who will be freely
chosen by physicians to prescribe vedolizumab at the end of consultation in the recruitment
period.
This multi-center trial will be conducted in France. The overall time to participate in this
study is 36 months, including participant's recruitment period of 12 months and treatment
period of 24 months. Participants will make a minimum of 4 follow-up visits to the clinic in
treatment period at Month 6, 12, 18, and 24.
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