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: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Tofacitinib

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• France
  • Amiens, France, 80090
    • Recruiting
    • Clinique de l Europe
  • Amiens, France, 80480
    • Recruiting
    • Hopital Sud
  • Besancon, France, 25003
    • Recruiting
    • Hopital Jean Minjoz
  • Caen, France, 14027
    • Recruiting
    • Hopital de La Cote de Nacre
  • Cahors, France, 46005
    • Recruiting
    • Centre Hospitalier de Cahors
  • Caluire, France, 69300
    • Recruiting
    • Infirmerie Protestante de Lyon
  • Chambray Les Tours, France, 37171
    • Recruiting
    • Hopital Trousseau
  • Clermont Ferrand, France, 63100
    • Recruiting
    • Hopital D'Estaing
  • Clichy Cedex, France, 92118
    • Recruiting
    • Aphp - Hopital Beaujon
  • Creteil Cedex, France, 94010
    • Recruiting
    • Ch Intercommunal de Creteil
  • Dunkerque, France, 59385
    • Recruiting
    • Ch Dunkerque
  • La Tronche, France, 38700
    • Recruiting
    • Hopital Albert Michallon
  • Le Kremlin Bicetre, France, 94275
    • Recruiting
    • Ch Bicetre
  • Le Mans, France, 72037
    • Recruiting
    • CH Le Mans
  • Le Puy En Velay, France, 43012
    • Recruiting
    • Ch Emile Roux
  • Lille, France, 59037
    • Recruiting
    • Hopital Claude Huriez
  • Lyon, France, 69365
    • Recruiting
    • Ch Saint Joseph Saint Luc
  • Montfermeil, France, 93370
    • Recruiting
    • Ch Montfermeil
  • Montpellier, France, 34070
    • Recruiting
    • Clinique Beau Soleil
  • Montpellier Cedex 5, France, 34295
    • Recruiting
    • Hopital Saint Eloi
  • Nantes, France, 44004
    • Recruiting
    • CHU Nantes
  • Nantes, France, 44014
    • Recruiting
    • Clinique Jules Verne
  • Nice, France, 06202
    • Recruiting
    • Hopital de L'Archet
  • Nimes, France, 30029
    • Recruiting
    • Hopital Caremeau
  • Paris, France, 75015
    • Recruiting
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75877
    • Recruiting
    • Chu Bichat Claude Bernard
  • Paris, France, 75674
    • Recruiting
    • Groupe Hospitalier Saint Joseph
  • Paris Cedex 10, France, 75466
    • Recruiting
    • Aphp - Hopital Saint Louis
  • Pessac, France, 33600
    • Recruiting
    • Chu de Bordeaux - Hopital Haut Leveque
  • Pierre Benite, France, 69495
    • Recruiting
    • CHU LYON
  • Pringy, France, 74374
    • Recruiting
    • Ch Annecy Genevois
  • Rennes, France, 35033
    • Recruiting
    • Chu Rennes
  • St Priest En Jarez Cedex, France, 42277
    • Recruiting
    • Hopital Nord
  • Toulouse, France, 31076
    • Recruiting
    • Clinique Pasteur
  • Toulouse cedex 04, France, 31403
    • Recruiting
    • Hopital Rangueil
  • Valence, France, 26953
    • Recruiting
    • Ch Valence
  • Valenciennes, France, 59322
    • Recruiting
    • Ch Valenciennes
  • Venissieux, France, 69694
    • Recruiting
    • 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 2 years 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 2 years is defined as a modified partial Mayo Score of 0 or 1 with rectal bleeding subscore of 0 and stool frequency subscore of 0 or 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: More than one oral or topical corticosteroid with systemic effects for UC for more than three months during the first 18 months; Oral corticosteroids for UC, between 18 and 24 months (whatever the duration of treatment),	Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with clinical benefit of tofacitinib at 2 years, for those still receiving tofacitinib at 2 years.		week 104
Predictors of the clinical benefit at 2 years identified from the available baseline data		Week 104
Proportion of patients in clinical remission and still receiving tofacitinib	Clinical remission is defined as partial Mayo score (PMS) <2	Week 52
Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC) at 1 year		Week 52
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 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 104
Proportion of patients with mucosal healing during the observation period	Mucosal healing is defined as endoscopic subscore of 0 or 1	Week 52
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
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 weeks
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

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 (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

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 (Estimated): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ulcerative Colitis, Tofacitinib, France, Real world data
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus 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.