Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

Last updated: January 29, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Crohn's Disease

Colic

Treatment

Tofacitinib

Clinical Study ID

NCT04424303
A3921360
TOFAst study
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 tofacitinibas per the French SmPC

  • Patients informed about the study procedures and receiving an information lettersigned by the investigator

Exclusion

Exclusion Criteria:

  • Patients who have already received tofacitinib treatment before baseline

  • Patients that fulfill any of the contrindications according to the latest version ofthe SmPC

Study Design

Total Participants: 280
Treatment Group(s): 1
Primary Treatment: Tofacitinib
Phase:
Study Start date:
December 04, 2020
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Clinique de l Europe

    Amiens, 80090
    France

    Site Not Available

  • Hopital Sud

    Amiens, 80480
    France

    Site Not Available

  • Hopital Jean Minjoz

    Besancon, 25003
    France

    Site Not Available

  • Hopital de La Cote de Nacre

    Caen, 14027
    France

    Active - Recruiting

  • Centre Hospitalier de Cahors

    Cahors, 46005
    France

    Site Not Available

  • Infirmerie Protestante de Lyon

    Caluire, 69300
    France

    Active - Recruiting

  • Hopital Trousseau

    Chambray Les Tours, 37171
    France

    Active - Recruiting

  • Hopital D'Estaing

    Clermont Ferrand, 63100
    France

    Active - Recruiting

  • Aphp - Hopital Beaujon

    Clichy Cedex, 92118
    France

    Site Not Available

  • Ch Intercommunal de Creteil

    Creteil Cedex, 94010
    France

    Active - Recruiting

  • Ch Dunkerque

    Dunkerque, 59385
    France

    Site Not Available

  • Hopital Albert Michallon

    La Tronche, 38700
    France

    Active - Recruiting

  • Ch Bicetre

    Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • CH Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • Ch Emile Roux

    Le Puy En Velay, 43012
    France

    Site Not Available

  • Hopital Claude Huriez

    Lille, 59037
    France

    Active - Recruiting

  • Ch Saint Joseph Saint Luc

    Lyon, 69365
    France

    Site Not Available

  • Ch Montfermeil

    Montfermeil, 93370
    France

    Site Not Available

  • Clinique Beau Soleil

    Montpellier, 34070
    France

    Site Not Available

  • Hopital Saint Eloi

    Montpellier Cedex 5, 34295
    France

    Active - Recruiting

  • Chu Nantes

    Nantes, 44004
    France

    Active - Recruiting

  • Clinique Jules Verne

    Nantes, 44014
    France

    Active - Recruiting

  • Hopital de L'Archet

    Nice, 06202
    France

    Site Not Available

  • Hopital Caremeau

    Nimes, 30029
    France

    Site Not Available

  • Chu Bichat Claude Bernard

    Paris, 75877
    France

    Site Not Available

  • Groupe Hospitalier Saint Joseph

    Paris, 75674
    France

    Active - Recruiting

  • Hopital Europeen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Aphp - Hopital Saint Louis

    Paris Cedex 10, 75466
    France

    Site Not Available

  • Chu de Bordeaux - Hopital Haut Leveque

    Pessac, 33600
    France

    Active - Recruiting

  • CHU LYON

    Pierre Benite, 69495
    France

    Site Not Available

  • Ch Annecy Genevois

    Pringy, 74374
    France

    Site Not Available

  • Chu Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • Hopital Nord

    St Priest En Jarez Cedex, 42277
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse, 31076
    France

    Active - Recruiting

  • Hopital Rangueil

    Toulouse cedex 04, 31403
    France

    Active - Recruiting

  • Ch Valence

    Valence, 26953
    France

    Site Not Available

  • Ch Valenciennes

    Valenciennes, 59322
    France

    Site Not Available

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Venissieux, 69694
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.