Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis (TOFAST)

Pfizer

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: Tofacitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04424303

TOFAst study (Other Identifier)

A3921360

Details and patient eligibility

About

This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

Full description

TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of 18 years old or above
• Patients with confirmed diagnosis of moderate to severe ulcerative colitis
• Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC
• Patients informed about the study procedures and receiving an information letter signed by the investigator

Exclusion criteria

• Patients who have already received tofacitinib treatment before baseline
• Patients that fulfill any of the contrindications according to the latest version of the SmPC

Trial design

152 participants in 1 patient group

Patients prescribed tofacitinib

Description:

Patients with a confirmed diagnosis of moderate to severe ulcerative colitis initiating tofacitinib as per the French summary of product characteristics (SmPC).

Treatment:

Drug: Tofacitinib