An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)
NCT Number: NCT06469424
Acronym: PASS TOFA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ulcerative Colitis
Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Collaborators: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-11
Completion Date: 2026-03-31
Locations: Imelda General Hospital, Bonheiden, 28202, Belgium|AZ Delta vzw, Roeselare, 8800, Belgium|Acibadem City Clinic Tokuda University Hospital, Sofia, 1407, Bulgaria|General Hospital of Athens "Evangelismos", Elliniko, Attiki, 16777, Greece|Lithuanian University of Life Sciences, Kaunas, 44307, Lithuania

Summary:
The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis \[DVT\] and pulmonary embolism \[PE\]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.

Primary Outcome Measures: Malignancy excluding non-melanoma skin cancer (NMSC), Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE]), deep venous thrombosis \[DVT\] and pulmonary embolism \[PE\]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025
Secondary Outcome Measures: Non melanoma skin cancer (NMSC), Non melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Lung cancer, Lung cancer. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Lymphoma, Lymphoma (including 3 main subtypes Hodgkin's lymphoma, non-Hodgkin's lymphoma, and chronic lymphocytic lymphoma).

As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Serious infections, Serious infections. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Opportunistic infections (e.g., tuberculosis), Opportunistic infections (e.g., tuberculosis). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Herpes zoster(HZ), Herpes zoster(HZ). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Major adverse cardiac events (MACE), Major adverse cardiac events (MACE), from 01 July 2018 through to 31 March 2025|Myocardial infarction (MI), Myocardial infarction (MI). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Progressive multifocal leukoencephalopathy (PML), Progressive multifocal leukoencephalopathy (PML). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Gastrointestinal (GI) perforations, Gastrointestinal (GI) perforations. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|Fractures, Fractures. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025|All-cause mortality, All-cause mortality, from 01 July 2018 through to 31 March 2025|surgery for Ulcerative colitis (UC), surgery for Ulcerative colitis (UC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event., from 01 July 2018 through to 31 March 2025