About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Patients not meeting the inclusion criteria
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].
Trial design
Treatments tested in this trial
- Not listed