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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier Cote Basque
Bayonne, France
Ch de Blois
Blois, France
Clinique du palais
Grasse, France
Ghef Ch Marne La Vallee
Jossigny, France
Ctre Hosp St Joseph Et St Luc
Lyon, France
Hopital Edouard Herriot
Lyon, France
Hopital Saint Eloi-Chru Montpellier
Montpellier, France
Ch Lyon Sud
Pierre-Bénite, France
Polyclinique Cote Basque Sud
Saint-Jean-de-Luz, France
HOPITAL NORD-CHU de SAINT-ETIENNE
Saint-Priest-en-Jarez, France
Start Date
February 13, 2018
Primary Completion Date
February 15, 2019
Completion Date
February 15, 2019
Last Updated
October 14, 2020
29
ACTUAL participants
Lead Sponsor
Takeda
NCT06226883
NCT05076175
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07245394