Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Recruiting now · Phase 4
Conditions studied: Ulcerative Colitis, Thromboembolism
In brief
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 facts
- Study ID
- NCT05313620
- Run by
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- People needed
- 30
- Starts
- 2022-04-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- EX VIVO STUDY IN PATIENTS WITH UC
- PATIENTS WITH UC:
- Over 18 years old.
- Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).
- Previous treatments are allowed, provided they have remained stable for the past 3 months.
- In the case of patients with active UC, they should have endoscopic activity within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).
- Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are:
- Intrauterine device (IUD).
- Bilateral tubal occlusion.
- Couple with vasectomy.
- Sexual abstinence.
- INDIVIDUALS WITHOUT UC:
- Over 18 years old.
- Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases.
- Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are:
- Intrauterine device (IUD).
- Bilateral tubal occlusion.
- Couple with vasectomy.
- Sexual abstinence.
- IN VIVO STUDY IN PATIENTS WITH UC
- PATIENTS WITH UC:
- Over 18 years old.
- Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).
- Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib.
- Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action.
You may not qualify if…
- EX VIVO STUDY IN PATIENTS WITH UC
- PATIENTS WITH UC:
- Under 18 years old.
- Immune-mediated disease, neoplasm or active infection.
- Pregnancy or lactation.
- Alcohol or drug abuse.
- Ostomy.
- Abdominal surgery in the last 6 months.
- Colectomy.
- Active infection with hepatitis B, C or HIV virus.
- Medical history of thromboembolic events.
- Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.
- Use of combined hormonal contraceptives or hormone replacement therapy.
- Hereditary coagulation disorders.
- Refusal to give consent for participation in the study.
- INDIVIDUALS WITHOUT UC:
- Under 18 years of age.
- Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.
- Pregnancy or lactation.
- Alcohol or drug abuse.
- Ostomy.
- Abdominal surgery in the last 6 months.
- Colectomy.
- Active infection with hepatitis B, C or HIV virus.
- Medical history of thromboembolic events.
Where it is running
- Hospital Universitario de La Princesa — Madrid, Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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