Effect of Tofacitinib on Coagulation and Platelet Function and Its Role in Thromboembolic Events in Ulcerative Colitis Patients

What this Trial Is About

Researchers are studying patients with ulcerative colitis (UC), a chronic disease causing inflammation in the colon with symptoms like bloody diarrhea and abdominal pain. This research focuses on evaluating the effects of tofacitinib, a JAK inhibitor, on blood clotting and platelet function, especially its role in causing thromboembolic events such as pulmonary embolism and deep vein thrombosis. The study compares patients treated with tofacitinib to those receiving anti-TNFb1 drugs and healthy individuals, aiming to better understand the safety profile of these treatments in UC. Patients with UC will receive either tofacitinib orally at 5 mg per day or one of the anti-TNFb1 drugs—infliximab by intravenous infusion, or adalimumab or golimumab by subcutaneous injection—according to usual clinical practice. Treatment choice is determined by the investigator, with no random assignment. The study includes both short and long-term follow-up, with assessments at baseline, 3 months, and 12 months to examine changes in coagulation and platelet activity. During the study, participants will undergo various evaluations including tests of platelet activation, endoscopic assessments of disease activity, response, and remission. The main outcome measured after one year is platelet activation, alongside secondary outcomes related to UC's endoscopic status. The trial monitors safety and the effects of treatment on blood clotting over time, with participants followed for at least 12 months. Healthy volunteers will also be included for comparison purposes.

Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events