Status:
TERMINATED
A Study to Assess the Effectiveness and Safety of Treatment With Vedolizumab in Adult Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real Life
Lead Sponsor:
Takeda
Conditions:
Colitis, Ulcerative
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Suffering from active disease of UC or CD according to the investigator's judgment.
- In failure or intolerant to a previous biologic treatment, or with contra-indication to anti-TNFalpha after failure of conventional treatments, regardless of the line of treatment.
- Meeting the same criteria as those described at the pre-screening.
- Prescription of vedolizumab during consultation.
- Able to be followed a priori over a period of 24 months.
Exclusion
- With exclusion criteria for vedolizumab and any contra-indication to vedolizumab: hypersensitivity to the active substance or to any of its excipients, active severe infections, such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
- Participation in an interventional study (but not in another non-interventional study).
- Unclassified colitis.
- Stomy.
Key Trial Info
Start Date :
February 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03378388
Start Date
February 13 2018
End Date
February 15 2019
Last Update
October 14 2020
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Cote Basque
Bayonne, France
2
Ch de Blois
Blois, France
3
Clinique du palais
Grasse, France
4
Ghef Ch Marne La Vallee
Jossigny, France