Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated March 17, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and/or vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-04-05; most recent amendment 2025-03-12.
Status change: Not Yet Recruiting → Recruiting 2022-08-02
Trial Details
NCT Number NCT05313620
Lead Sponsor Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Conditions Ulcerative Colitis, Thromboembolism
Enrollment 30 participants
Start Date 2022-04-01
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-17