Status:
TERMINATED
Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Brief Summary
The overarching goal of this study, is to create a longitudinally followed, well phenotyped cohort of patients with UC starting treatment with tofacitinib in the setting of standard of care who have l...
Detailed Description
The proposed prospective tofacitinib registry is a prospective patient cohort with the goal of evaluating the efficacy and safety of this drug in "real life". All patients starting tofacitinib for ulc...
Eligibility Criteria
Inclusion
- Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on tofacitinib therapy for moderate to severe UC or who plan to start this therapy within the next 2 weeks. The start of the tofacitinib therapy must have been or be initiated in the setting of standard of care therapy
- Anticipation that the patient will be followed by the participating center at least for the next 12 months
- Diagnosis of UC must be established on the basis of standard clinical, radiographic, endoscopic, and histologic criteria as described below.
Exclusion
- 1\. Patients will be excluded if they meet any of the following criteria:
- Inability to provide informed consent
- Patients presenting for a one-time consultation
Key Trial Info
Start Date :
November 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 29 2024
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03772145
Start Date
November 27 2018
End Date
January 29 2024
Last Update
January 31 2024
Active Locations (1)
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1
Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina, United States, 27599