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

Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Tofacitinib

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80090
    • Clinique de L Europe
  • Amiens, France, 80480
    • Hopital Sud
  • Besançon, France, 25003
    • Hopital Jean Minjoz
  • Caen, France, 14027
    • Hôpital de la Côte de Nacre
  • Cahors, France, 46005
    • Centre Hospitalier de Cahors
  • Caluire-et-Cuire, France, 69300
    • Infirmerie Protestante de Lyon
  • Chambray-lès-Tours, France, 37171
    • Hôpital Trousseau
  • Clermont-Ferrand, France, 63100
    • Hôpital d'Estaing
  • Clichy, France, 92118
    • APHP - Hôpital Beaujon
  • Créteil, France, 94010
    • Ch Intercommunal de Creteil
  • Dunkirk, France, 59385
    • Ch Dunkerque
  • La Tronche, France, 38700
    • Hôpital Albert Michallon
  • Le Kremlin-Bicêtre, France, 94275
    • Ch Bicetre
  • Le Mans, France, 72037
    • CH Le mans
  • Le Puy-en-Velay, France, 43012
    • CH Emile Roux
  • Lille, France, 59037
    • Hopital Claude Huriez
  • Lyon, France, 69365
    • CH Saint Joseph Saint Luc
  • Montfermeil, France, 93370
    • Ch Montfermeil
  • Montpellier, France, 34295
    • Hopital Saint Eloi
  • Montpellier, France, 34070
    • Clinique Beau Soleil
  • Nantes, France, 44004
    • CHU Nantes
  • Nantes, France, 44014
    • Clinique Jules Verne
  • Nice, France, 06202
    • Hôpital de l'Archet
  • Nîmes, France, 30029
    • Hopital Caremeau
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75466
    • APHP - Hôpital Saint Louis
  • Paris, France, 75674
    • Groupe Hospitalier Saint Joseph
  • Paris, France, 75877
    • Chu Bichat Claude Bernard
  • Pessac, France, 33600
    • CHU de Bordeaux - Hôpital Haut Lévêque
  • Pierre-Bénite, France, 69495
    • CHU Lyon
  • Pringy, France, 74374
    • Ch Annecy Genevois
  • Rennes, France, 35033
    • Chu Rennes
  • Saint-Priest-en-Jarez, France, 42277
    • Hopital Nord
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Toulouse, France, 31403
    • Hopital Rangueil
  • Valence, France, 26953
    • CH Valence
  • Valenciennes, France, 59322
    • Ch Valenciennes
  • Vénissieux, France, 69694
    • Groupe Hospitalier Mutualiste Les Portes du Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with moderate to severe Ulcerative Colitis initiating tofacitinib treatment as per the French Summary of product characteristics (SmPC)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Drug: Tofacitinib; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment.	The definition of clinical benefit is independent of the discontinuation or not of tofacitinib treatment during the observation period. Clinical benefit at year is defined on the basis of symptomatic remission evaluated with the PRO2 score ≤1 (absence of rectal bleeding and a stool frequency score between 0 and 1)*. Patients who died or who had a colectomy or used another biologic/anti-JAK/immunosuppressant will be considered to be non-responders, as well as patients who used oal corticosteroids for UC, (regardless of the treatment duration) during the 3 months preceding the end of the observation period. The clinical benefit of tofacitinib is independent of the administration or not of 5-ASA, or corticosteroids (not complying with the above definition) during the observation period (between 0 and 1 year).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with short-term clinical response for patients still treated with tofacitinib	Clinical response is defined as a reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1).	Approximately week 8 and 16
Proportion of patients in sustained clinical remission	Clinical remission is defined as partial Mayo score (PMS) <2 at 52 and 104 weeks	Week 52 and 104
Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction	The clinical loss of response is defined by a recrudescence of the symptoms that lead to a systemic therapeutic intervention (return to previous dose of tofacitinib or corticosteroid therapy, or an immunosuppressant or biologic/other anti-JAK)	Week 8, 16, 24, 72, 52 and 104
Proportion of patients with extraintestinal manifestations at each visit		Week 8, 16, 24, 72, 52, 104
Proportion of patients with a colectomy during study follow-up and time of occurrence		Week 8, 16, 24, 72,52 and 104
Characteristics of patients and UC, on the basis of all the data collected at baseline		Week 104
Change in patient quality-of-life evaluated from the SIBDQ questionnaire between baseline and 1 year, baseline and 2 years, and between 1 and 2 years		Week 52, Week 52 to week 104 and week 104
Change in adherence to tofacitinib treatment during each visit	Using MARS questionnaire	Week 8, 16, 24, 72, 52, 104
Proportion of patients with serious and non-serious adverse events.		Week 8, 16, 24,72,52 and 104
Proportion of patients with clinical benefit of tofacitinib at 2 years		week 104
Predictors of the clinical benefit at one year identified from the available baseline data		Week 52
Proportion of patients in clinical remission and still receiving tofacitinib	Clinical remission is defined as partial Mayo score (PMS) <2	Week 52 and Week 104
Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC)		Week 52 and week 104
Proportion of patients with biological response during the observation period	Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP)	Week 52 and 104
Proportion of patients with endoscopic improvement during the observation period	endoscopic improvement is defined as endoscopic subscore of 0 or 1	Week 52 and 104
Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy	(self-assessment by patients)	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a clinical response* 1 year and 2 years after initiation of tofacitinib	Reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1).	Week 52 and 104

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): December 8, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis, Tofacitinib, France, Real world data
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; tofacitinib
• Other Study ID Numbers: A3921360; TOFAst study (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.