Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— TOFAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424303
• Other study ID #: A3921360
• Secondary ID: TOFAst study
• Status: Recruiting
• Start date: December 4, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Tofacitinib
Observational study

Locations

Country	Name	City	State
France	Clinique de l Europe	Amiens
France	Hopital Sud	Amiens
France	Hopital Jean Minjoz	Besancon
France	Hopital de La Cote de Nacre	Caen
France	Centre Hospitalier de Cahors	Cahors
France	Infirmerie Protestante de Lyon	Caluire
France	Hopital Trousseau	Chambray Les Tours
France	Hopital D'Estaing	Clermont Ferrand
France	Aphp - Hopital Beaujon	Clichy Cedex
France	Ch Intercommunal de Creteil	Creteil Cedex
France	Ch Dunkerque	Dunkerque
France	Hopital Albert Michallon	La Tronche
France	Ch Bicetre	Le Kremlin Bicetre
France	CH Le Mans	Le Mans
France	Ch Emile Roux	Le Puy En Velay
France	Hopital Claude Huriez	Lille
France	Ch Saint Joseph Saint Luc	Lyon
France	Ch Montfermeil	Montfermeil
France	Clinique Beau Soleil	Montpellier
France	Hopital Saint Eloi	Montpellier Cedex 5
France	Chu Nantes	Nantes
France	Clinique Jules Verne	Nantes
France	Hopital de L'Archet	Nice
France	Hopital Caremeau	Nimes
France	Chu Bichat Claude Bernard	Paris
France	Groupe Hospitalier Saint Joseph	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Aphp - Hopital Saint Louis	Paris Cedex 10
France	Chu de Bordeaux - Hopital Haut Leveque	Pessac
France	CHU LYON	Pierre Benite
France	Ch Annecy Genevois	Pringy
France	Chu Rennes	Rennes
France	Hopital Nord	St Priest En Jarez Cedex
France	Clinique Pasteur	Toulouse
France	Hopital Rangueil	Toulouse cedex 04
France	Ch Valence	Valence
France	Ch Valenciennes	Valenciennes
France	Groupe Hospitalier Mutualiste Les Portes du Sud	Venissieux

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients with clinical benefit of tofacitinib at 2 years, for those still receiving tofacitinib at 2 years.		week 104
Secondary	Predictors of the clinical benefit at 2 years identified from the available baseline data		Week 104
Secondary	Proportion of patients in clinical remission and still receiving tofacitinib	Clinical remission is defined as partial Mayo score (PMS) <2	Week 52
Secondary	Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC) at 1 year		Week 52
Secondary	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
Secondary	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
Secondary	Proportion of patients with mucosal healing during the observation period	Mucosal healing is defined as endoscopic subscore of 0 or 1	Week 52
Secondary	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
Secondary	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
Secondary	Proportion of patients with extraintestinal manifestations at each visit		Week 8, 16, 24, 72, 52, 104
Secondary	Proportion of patients with a colectomy during study follow-up and time of occurrence		Week 8, 16, 24, 72,52 and 104
Secondary	Characteristics of patients and UC, on the basis of all the data collected at baseline		Week 104
Secondary	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
Secondary	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
Secondary	Change in adherence to tofacitinib treatment during each visit	Using MARS questionnaire	Week 8, 16, 24, 72, 52, 104
Secondary	Proportion of patients with serious and non-serious adverse events.		Week 8, 16, 24,72,52 and 104

External Links

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