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
2 other identifiers
observational
152
1 country
38
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Longer than P75 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
December 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2025
CompletedJanuary 15, 2026
January 1, 2026
5 years
June 8, 2020
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
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
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 short-term clinical response for patients still treated with tofacitinib
Approximately week 8 and 16
- +11 more secondary outcomes
Other Outcomes (1)
Proportion of patients with a clinical response* 1 year and 2 years after initiation of tofacitinib
Week 52 and 104
Study Arms (1)
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).
Interventions
Eligibility Criteria
Adult patients with moderate to severe Ulcerative Colitis initiating tofacitinib treatment as per the French Summary of product characteristics (SmPC)
You may qualify if:
- 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
You may not qualify if:
- Patients who have already received tofacitinib treatment before baseline
- Patients that fulfill any of the contrindications according to the latest version of the SmPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (38)
Clinique de l Europe
Amiens, 80090, France
Hopital Sud
Amiens, 80480, France
Hopital Jean Minjoz
Besançon, 25003, France
Hopital de La Cote de Nacre
Caen, 14027, France
Centre Hospitalier de Cahors
Cahors, 46005, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300, France
Hopital Trousseau
Chambray-lès-Tours, 37171, France
Hopital D'Estaing
Clermont-Ferrand, 63100, France
Aphp - Hopital Beaujon
Clichy, 92118, France
Ch Intercommunal de Creteil
Créteil, 94010, France
Ch Dunkerque
Dunkirk, 59385, France
Hopital Albert Michallon
La Tronche, 38700, France
Ch Bicetre
Le Kremlin-Bicêtre, 94275, France
CH Le Mans
Le Mans, 72037, France
Ch Emile Roux
Le Puy-en-Velay, 43012, France
Hopital Claude Huriez
Lille, 59037, France
Ch Saint Joseph Saint Luc
Lyon, 69365, France
Ch Montfermeil
Montfermeil, 93370, France
Clinique Beau Soleil
Montpellier, 34070, France
Hopital Saint Eloi
Montpellier, 34295, France
Chu Nantes
Nantes, 44004, France
Clinique Jules Verne
Nantes, 44014, France
Hopital de L'Archet
Nice, 06202, France
Hopital Caremeau
Nîmes, 30029, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Aphp - Hopital Saint Louis
Paris, 75466, France
Groupe Hospitalier Saint Joseph
Paris, 75674, France
Chu Bichat Claude Bernard
Paris, 75877, France
Chu de Bordeaux - Hopital Haut Leveque
Pessac, 33600, France
CHU LYON
Pierre-Bénite, 69495, France
Ch Annecy Genevois
Pringy, 74374, France
Chu Rennes
Rennes, 35033, France
Hopital Nord
Saint-Priest-en-Jarez, 42277, France
Clinique Pasteur
Toulouse, 31076, France
Hopital Rangueil
Toulouse, 31403, France
Ch Valence
Valence, 26953, France
Ch Valenciennes
Valenciennes, 59322, France
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, 69694, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 9, 2020
Study Start
December 4, 2020
Primary Completion
December 8, 2025
Study Completion
December 8, 2025
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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.