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

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

Plain Language Summary

Simplified for easier understanding

This is an observational safety study tracking real-world outcomes for patients with ulcerative colitis (UC) who are taking tofacitinib, a medication used to control UC symptoms. The study collects data through an existing European patient registry rather than testing a new treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of ulcerative colitis - You are enrolled in the UR-CARE registry in the European Union with at least 12 months of medical history on record - You have signed informed consent - You are starting tofacitinib as your treatment **You may NOT be eligible if...** - You have a history of Crohn's disease or unspecified inflammatory bowel disease in the registry records - You do not meet the inclusion criteria above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(5)

Imelda General Hospital

Bonheiden, Belgium

AZ Delta vzw

Roeselare, Belgium

Acibadem City Clinic Tokuda University Hospital

Sofia, Bulgaria

General Hospital of Athens "Evangelismos"

Ellinikó, Attica, Greece

Lithuanian University of Life Sciences

Kaunas, Lithuania

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NCT06469424


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