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)

Launched by GRUPO ESPANOL DE TRABAJO EN ENFERMEDAD DE CROHN Y COLITIS ULCEROSA · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of a medication called tofacitinib for adults with moderately to severely active ulcerative colitis, a condition that causes inflammation in the colon. The study aims to gather real-world data on potential health risks associated with tofacitinib, such as the chances of developing certain cancers, blood clots, serious infections, heart problems, and other serious health issues. Researchers will compare the safety of tofacitinib to other approved medications for ulcerative colitis.

To participate in this study, you need to be at least 18 years old and have a diagnosis of ulcerative colitis according to specific guidelines. You must also be enrolled in a registry called UR-CARE and have a medical history available for at least 12 months before starting the medication. If you join the study, you can expect to be monitored for at least a year to help researchers understand the safety of tofacitinib in everyday medical care. It’s important to know that this study is currently recruiting participants, and your involvement could help improve treatment options for others with this condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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 \[i.e. date of first prescription for tofacitinib\].