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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)

NCT06469424 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2024-06-21

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

    lead OTHER

Principal Investigators

  • Manuel MD Barreiro, PhD · Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2025-03-31
Completion
2026-03-31

Countries

  • Belgium
  • Bulgaria
  • Greece
  • Lithuania

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469424 on ClinicalTrials.gov