RecruitingPhase 4NCT05313620

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


Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Enrollment

30 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether tofacitinib — a medication used to treat ulcerative colitis (UC), an inflammatory bowel disease — affects blood clotting and platelet function, and whether those effects are linked to the increased risk of blood clots (thromboembolism) seen with this drug class. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with ulcerative colitis according to established criteria - Your treatments have been stable for the past 3 months - If you have active UC, you had an endoscopy within the past month showing active disease - Women of childbearing age are using highly effective contraception (IUD, bilateral tubal ligation, partner vasectomy, or abstinence) - People without UC may also participate as a comparison group **You may NOT be eligible if...** - You have a known bleeding disorder or are on anticoagulants that would affect the study results - You have had a recent blood clot or stroke 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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Interventions

DRUGTofacitinib

Tofacitinib 5 MG/day per clinical practice

DRUGInfliximab Adalimumab y Golimumab

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice or or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice.


Locations(1)

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

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NCT05313620


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