Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

NCT04424303

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients who have already received tofacitinib treatment before baseline


- Patients that fulfill any of the contrindications according to the latest version of
the SmPC

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Advanced Information
Descriptive Information
Brief Title 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
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Ulcerative Colitis
Intervention Drug: Tofacitinib
Observational study
Study Groups/Cohorts 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).
Intervention: Drug: Tofacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 8, 2020)
280
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04424303
Other Study ID Numbers A3921360
TOFAst study ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020