RecruitingNCT06469424

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)

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Enrollment

104 participants

Start Date

Jan 11, 2024

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Adult patients aged ≥18 years,
With Ulcerative colitis diagnosis per ECCO guidelines,
Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,
With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.
Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date \[i.e. date of first prescription for tofacitinib\].