Actively Recruiting
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Led by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Updated on 2025-03-17
30
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be over 18 years old.
- Diagnosis of ulcerative colitis according to European Crohn's and Colitis Organisation criteria.
- Previous treatments should have been stable for the last 3 months.
- For active UC patients, endoscopic activity must be within 1 month before starting treatment (Mayo sub-index 2 2).
- Women of childbearing age must use contraceptive methods with less than 1% failure rate per year (IUD, tubal occlusion, partner vasectomy, or sexual abstinence).
- Indication for treatment with anti-TNF (infliximab, adalimumab, golimumab) or tofacitinib.
- First treatment with a JAK inhibitor or anti-TNF drug with the given mechanism of action.
- For participants without UC: over 18 years old, no diagnosis of UC or other inflammatory, allergic, malignant, or autoimmune diseases, and use of effective contraception as above.
You will not qualify if you...
- Under 18 years old.
- Presence of immune-mediated diseases, neoplasm, or active infection.
- Pregnancy or breastfeeding.
- Alcohol or drug abuse.
- Ostomy or colectomy.
- Abdominal surgery in the last 6 months.
- Active infection with hepatitis B, C, or HIV virus.
- Medical history of thromboembolic events.
- Current treatment with anticoagulants, antiplatelets, or other drugs affecting coagulation.
- Use of combined hormonal contraceptives or hormone replacement therapy.
- Hereditary coagulation disorders.
- For in vivo study: indication of anti-TNF or JAK-inhibitor treatment for diseases other than UC.
- Prior treatment with drugs of the same mechanism of action (anti-TNF or JAK inhibitors).
- For individuals without UC: advanced chronic disease or pathology preventing study monitoring, macroscopic alterations on colonoscopy, or relevant inflammatory biopsy findings.
- Treatment with immunomodulators, immunosuppressants, corticosteroids, or other immune-altering drugs.
- Refusal to consent to participate in the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario de La Princesa
Madrid, Madrid, Spain, 28006
Actively Recruiting
Research Team
S
Sandra Hermida
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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