A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD) (CHRONOS)

Takeda

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02986724

Vedolizumab-4017

Details and patient eligibility

About

The purpose of this non-interventional study (NIS) study is to assess further knowledge on the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in participants with CD and UC naive to biologics.

Full description

The drug being tested in this prospective, observational study is called vedolizumab. Vedolizumab (Entyvio) is being used to treat people who have CD or UC. This study will look in the routine use of vedolizumab in inflammatory bowel disease therapy in participants with CD or UC who did not receive a biologic treatment before. The study will enroll approximately 150 participants. All participants enrolled in this will belong to one observational group: Vedolizumab.

Participants taking vedolizumab as per physician's prescription in routine clinical practice will be observed.

This multi-centre trial will be conducted in Austria. The overall time to participate in this study is 2 years. Participant taking vedolizumab in routine clinical practice will make multiple visits to the clinic at Baseline, Week 20 and 52. Once a participant is switched to subsequent biologic treatment upon failing treatment with vedolizumab, the switching date will be considered as new baseline followed by visits at Week 20 and 52.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1 Initiating vedolizumab for moderately to severely active UC or CD. Exclusion Criteria

1. Participant is enrolled in a clinical trial in which treatment for UC or CD is managed through a protocol,
2. Prior treatment with a biologic agent,
3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Trial design

60 participants in 1 patient group

Vedolizumab

Description:

Bio-naïve participants with UC or CD will be treated with vedolizumab as per local prescriptions from physician in routine medical practice for up to 52 Week. Participants who fail on vedolizumab may be switched during the study to another biologic treatment as prescribed by the physician during routine medical practice for up to 52 Weeks.