Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

NCT ID: NCT04424303

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-04

Study Completion Date

2025-12-08

Brief Summary

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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

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients prescribed tofacitinib

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

Tofacitinib

Intervention Type DRUG

Observational study

Interventions

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Tofacitinib

Observational study

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Clinique de l Europe

Amiens, , France

Site Status

Hopital Sud

Amiens, , France

Site Status

Hopital Jean Minjoz

Besançon, , France

Site Status

Hopital de La Cote de Nacre

Caen, , France

Site Status

Centre Hospitalier de Cahors

Cahors, , France

Site Status

Infirmerie Protestante de Lyon

Caluire-et-Cuire, , France

Site Status

Hopital Trousseau

Chambray-lès-Tours, , France

Site Status

Hopital D'Estaing

Clermont-Ferrand, , France

Site Status

Aphp - Hopital Beaujon

Clichy, , France

Site Status

Ch Intercommunal de Creteil

Créteil, , France

Site Status

Ch Dunkerque

Dunkirk, , France

Site Status

Hopital Albert Michallon

La Tronche, , France

Site Status

Ch Bicetre

Le Kremlin-Bicêtre, , France

Site Status

CH Le Mans

Le Mans, , France

Site Status

Ch Emile Roux

Le Puy-en-Velay, , France

Site Status

Hopital Claude Huriez

Lille, , France

Site Status

Ch Saint Joseph Saint Luc

Lyon, , France

Site Status

Ch Montfermeil

Montfermeil, , France

Site Status

Clinique Beau Soleil

Montpellier, , France

Site Status

Hopital Saint Eloi

Montpellier, , France

Site Status

Chu Nantes

Nantes, , France

Site Status

Clinique Jules Verne

Nantes, , France

Site Status

Hopital de L'Archet

Nice, , France

Site Status

Hopital Caremeau

Nîmes, , France

Site Status

Hopital Europeen Georges Pompidou

Paris, , France

Site Status

Aphp - Hopital Saint Louis

Paris, , France

Site Status

Groupe Hospitalier Saint Joseph

Paris, , France

Site Status

Chu Bichat Claude Bernard

Paris, , France

Site Status

Chu de Bordeaux - Hopital Haut Leveque

Pessac, , France

Site Status

CHU LYON

Pierre-Bénite, , France

Site Status

Ch Annecy Genevois

Pringy, , France

Site Status

Chu Rennes

Rennes, , France

Site Status

Hopital Nord

Saint-Priest-en-Jarez, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Hopital Rangueil

Toulouse, , France

Site Status

Ch Valence

Valence, , France

Site Status

Ch Valenciennes

Valenciennes, , France

Site Status

Groupe Hospitalier Mutualiste Les Portes du Sud

Vénissieux, , France

Site Status

Countries

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France

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A3921360

To obtain contact information for a study center near you, click here.

Other Identifiers

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TOFAst study

Identifier Type: OTHER

Identifier Source: secondary_id

A3921360

Identifier Type: -

Identifier Source: org_study_id

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