Clinical trial NCT04424303: Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, Tofacitinib, France, Real world data
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment.
timeFrame: Week 52
Secondary outcomes:
measure: Proportion of patients with clinical benefit of tofacitinib at 2 years
timeFrame: week 104
measure: Predictors of the clinical benefit at one year identified from the available baseline data
timeFrame: Week 52
measure: Proportion of patients in clinical remission and still receiving tofacitinib
timeFrame: Week 52 and Week 104
measure: Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC)
timeFrame: Week 52 and week 104
measure: Proportion of patients with short-term clinical response for patients still treated with tofacitinib
timeFrame: Approximately week 8 and 16
measure: Proportion of patients with biological response during the observation period
timeFrame: Week 52 and 104
measure: Proportion of patients with endoscopic improvement during the observation period
timeFrame: Week 52 and 104
measure: Proportion of patients in sustained clinical remission
timeFrame: Week 52 and 104
measure: Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction
timeFrame: Week 8, 16, 24, 72, 52 and 104
measure: Proportion of patients with extraintestinal manifestations at each visit
timeFrame: Week 8, 16, 24, 72, 52, 104
measure: Proportion of patients with a colectomy during study follow-up and time of occurrence
timeFrame: Week 8, 16, 24, 72,52 and 104
measure: Characteristics of patients and UC, on the basis of all the data collected at baseline
timeFrame: Week 104
measure: Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy
timeFrame: 14 days
measure: 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
timeFrame: Week 52, Week 52 to week 104 and week 104
measure: Change in adherence to tofacitinib treatment during each visit
timeFrame: Week 8, 16, 24, 72, 52, 104
measure: Proportion of patients with serious and non-serious adverse events.
timeFrame: Week 8, 16, 24,72,52 and 104
Other outcomes:
measure: Proportion of patients with a clinical response* 1 year and 2 years after initiation of tofacitinib
timeFrame: Week 52 and 104
Locations:
city: Amiens
country: France
facility: Clinique de l Europe
city: Amiens
country: France
facility: Hopital Sud
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Caen
country: France
facility: Hopital de La Cote de Nacre
city: Cahors
country: France
facility: Centre Hospitalier de Cahors
city: Caluire
country: France
facility: Infirmerie Protestante de Lyon
city: Chambray Les Tours
country: France
facility: Hopital Trousseau
city: Clermont Ferrand
country: France
facility: Hopital D'Estaing
city: Clichy Cedex
country: France
facility: Aphp - Hopital Beaujon
city: Creteil Cedex
country: France
facility: Ch Intercommunal de Creteil
city: Dunkerque
country: France
facility: Ch Dunkerque
city: La Tronche
country: France
facility: Hopital Albert Michallon
city: Le Kremlin Bicetre
country: France
facility: Ch Bicetre
city: Le Mans
country: France
facility: CH Le Mans
city: Le Puy En Velay
country: France
facility: Ch Emile Roux
city: Lille
country: France
facility: Hopital Claude Huriez
city: Lyon
country: France
facility: Ch Saint Joseph Saint Luc
city: Montfermeil
country: France
facility: Ch Montfermeil
city: Montpellier Cedex 5
country: France
facility: Hopital Saint Eloi
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Nantes
country: France
facility: Chu Nantes
city: Nantes
country: France
facility: Clinique Jules Verne
city: Nice
country: France
facility: Hopital de L'Archet
city: Nimes
country: France
facility: Hopital Caremeau
city: Paris Cedex 10
country: France
facility: Aphp - Hopital Saint Louis
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Groupe Hospitalier Saint Joseph
city: Paris
country: France
facility: Chu Bichat Claude Bernard
city: Pessac
country: France
facility: Chu de Bordeaux - Hopital Haut Leveque
city: Pierre Benite
country: France
facility: CHU LYON
city: Pringy
country: France
facility: Ch Annecy Genevois
city: Rennes
country: France
facility: Chu Rennes
city: St Priest En Jarez Cedex
country: France
facility: Hopital Nord
city: Toulouse cedex 04
country: France
facility: Hopital Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Valence
country: France
facility: Ch Valence
city: Valenciennes
country: France
facility: Ch Valenciennes
city: Venissieux
country: France
facility: Groupe Hospitalier Mutualiste Les Portes du Sud
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: