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RECRUITING
NCT05313620
PHASE4

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

Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-04-01

Completion Date

2025-12

Last Updated

2025-03-17

Healthy Volunteers

Yes

Interventions

DRUG

Tofacitinib

Tofacitinib 5 MG/day per clinical practice

DRUG

Infliximab 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