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)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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

Trial groups

104 Participants
are grouped into 4 trial groups