Status:
RECRUITING
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Lead Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Conditions:
Ulcerative Colitis
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 (tofaciti...
Detailed Description
BACKGROUND Ulcerative colitis (UC) is a chronic pathology that causes inflammation of the colonic mucosa (1, 2). The most common symptoms include bloody diarrhea, abdominal pain, and urgent bowel mov...
Eligibility Criteria
Inclusion
- 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.
- Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).
- Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months before beginning treatment with JAK-inhibitor or anti-TNFα and that they are maintained at a stable dose for the duration of the study
- 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.
Exclusion
- 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.
- 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.
- IN 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.
- Colectomy.
- Active infection with hepatitis B, C or HIV virus.
- Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC.
- Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors)
- 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.
- Active infection with hepatitis B, C or HIV virus.
- Finding of macroscopic alterations during the colonoscopy or finding of relevant inflammatory alterations in the biopsies obtained during the colonoscopy.
- Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.
- 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.
- Abdominal surgery in the last 6 months.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05313620
Start Date
April 1 2022
End Date
December 1 2025
Last Update
March 17 2025
Active Locations (1)
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1
Hospital Universitario de La Princesa
Madrid, Madrid, Spain, 28006