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 (GEVOL)

Takeda

Status: Terminated

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03378388

U1111-1203-0268 (Registry Identifier)

Vedolizumab-5039

Details and patient eligibility

About

The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

Full 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 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Suffering from active disease of UC or CD according to the investigator's judgment.
2. 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.
3. Meeting the same criteria as those described at the pre-screening.
4. Prescription of vedolizumab during consultation.
5. Able to be followed a priori over a period of 24 months.

Exclusion criteria

1. 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).
2. Participation in an interventional study (but not in another non-interventional study).
3. Unclassified colitis.
4. Stomy.

Trial design

29 participants in 1 patient group

Vedolizumab

Description:

Participants diagnosed with UC or CD, who fail or are intolerant to a previous biologic treatment or with contra-indication to anti-tumor necrosis factor alpha (TNF alpha) after failure of conventional treatments without exclusion except participant refusal, and were potentially eligible for a treatment with vedolizumab will be observed from the first prescription during consultation over a period of 24 months.