Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis
NCT04424303
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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
- 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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Descriptive Information | |||||
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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 | 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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | August 2020 |