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

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ClinicalTrials.gov Identifier: NCT04424303
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Ulcerative Colitis Drug: Tofacitinib

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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 4, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of patients with clinical benefit 2 years after initiation of tofacitinib treatment. [ Time Frame: Week 104 ]

    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:

    1. More than one oral or topical corticosteroid with systemic effects for UC for more than three months during the first 18 months
    2. Oral corticosteroids for UC, between 18 and 24 months (whatever the duration of treatment),


Secondary Outcome Measures :
  1. Proportion of patients with clinical benefit of tofacitinib at 2 years, for those still receiving tofacitinib at 2 years. [ Time Frame: week 104 ]
  2. Predictors of the clinical benefit at 2 years identified from the available baseline data [ Time Frame: Week 104 ]
  3. Proportion of patients in clinical remission and still receiving tofacitinib [ Time Frame: Week 52 ]
    Clinical remission is defined as partial Mayo score (PMS) <2

  4. Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC) at 1 year [ Time Frame: Week 52 ]
  5. 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).

  6. Proportion of patients with biological response during the observation period [ Time Frame: Week 104 ]
    Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP)

  7. Proportion of patients with mucosal healing during the observation period [ Time Frame: Week 52 ]
    Mucosal healing is defined as endoscopic subscore of 0 or 1

  8. 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

  9. 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)

  10. Proportion of patients with extraintestinal manifestations at each visit [ Time Frame: Week 8, 16, 24, 72, 52, 104 ]
  11. Proportion of patients with a colectomy during study follow-up and time of occurrence [ Time Frame: Week 8, 16, 24, 72,52 and 104 ]
  12. Characteristics of patients and UC, on the basis of all the data collected at baseline [ Time Frame: Week 104 ]
  13. 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 weeks ]
    (self-assessment by patients)

  14. 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 ]
  15. Change in adherence to tofacitinib treatment during each visit [ Time Frame: Week 8, 16, 24, 72, 52, 104 ]
    Using MARS questionnaire

  16. Proportion of patients with serious and non-serious adverse events. [ Time Frame: Week 8, 16, 24,72,52 and 104 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424303


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04424303    
Other Study ID Numbers: A3921360
TOFAst study ( Other Identifier: Alias Study Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
Ulcerative Colitis, Tofacitinib, France, Real world data
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action