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

Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study ID
NCT05313620
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tofacitinib — DRUG
    Tofacitinib 5 MG/day per clinical practice
  • Infliximab Adalimumab y Golimumab — DRUG
    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.

Study Details

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 Dates

Start date
Apr 1, 2022
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ulcerative colitis patients treated with tofacitinib
    Tofacitinib 5 mg/day oral per clinical practice
  • Active Comparator: Ulcerative colitis patients treated with an anti-TNFα drug
    Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice, or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice, or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice
  • No Intervention: healthy controls

Primary Outcome Measure

platelet activation [ Time Frame: 1 year ]

Central Contacts

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