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

January 13, 2026 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France, 80090
        • Clinique de L Europe
      • Amiens, France, 80480
        • Hopital Sud
      • Besançon, France, 25003
        • Hôpital 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
        • Hôpital 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
        • Hopital Europeen 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 Leveque
      • 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
        • Hôpital Rangueil
      • Valence, France, 26953
        • CH VALENCE
      • Valenciennes, France, 59322
        • Ch Valenciennes
      • Vénissieux, France, 69694
        • Groupe Hospitalier Mutualiste Les Portes du Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment.
Time Frame: Week 52

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with short-term clinical response for patients still treated with tofacitinib
Time Frame: Approximately week 8 and 16
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
Time Frame: Week 52 and 104
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
Time Frame: Week 8, 16, 24, 72, 52 and 104
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
Time Frame: Week 8, 16, 24, 72, 52, 104
Week 8, 16, 24, 72, 52, 104
Proportion of patients with a colectomy during study follow-up and time of occurrence
Time Frame: Week 8, 16, 24, 72,52 and 104
Week 8, 16, 24, 72,52 and 104
Characteristics of patients and UC, on the basis of all the data collected at baseline
Time Frame: Week 104
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
Time Frame: Week 52, Week 52 to week 104 and week 104
Week 52, Week 52 to week 104 and week 104
Change in adherence to tofacitinib treatment during each visit
Time Frame: Week 8, 16, 24, 72, 52, 104
Using MARS questionnaire
Week 8, 16, 24, 72, 52, 104
Proportion of patients with serious and non-serious adverse events.
Time Frame: Week 8, 16, 24,72,52 and 104
Week 8, 16, 24,72,52 and 104
Proportion of patients with clinical benefit of tofacitinib at 2 years
Time Frame: week 104
week 104
Predictors of the clinical benefit at one year identified from the available baseline data
Time Frame: Week 52
Week 52
Proportion of patients in clinical remission and still receiving tofacitinib
Time Frame: Week 52 and Week 104
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)
Time Frame: Week 52 and week 104
Week 52 and week 104
Proportion of patients with biological response during the observation period
Time Frame: Week 52 and 104
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
Time Frame: Week 52 and 104
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
Time Frame: 14 days
(self-assessment by patients)
14 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with a clinical response* 1 year and 2 years after initiation of tofacitinib
Time Frame: Week 52 and 104
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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