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

Launched by FUNDACIÓN DE INVESTIGACIÓN BIOMÉDICA - HOSPITAL UNIVERSITARIO DE LA PRINCESA · Apr 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called tofacitinib on blood clotting and platelet function in patients with ulcerative colitis (UC). Researchers want to understand how this treatment might lower the risk of blood clots, which can be a serious health concern. The trial is taking place at the Hospital Universitario de La Princesa, and it will include patients aged 18 and older who have been diagnosed with UC. Participants may be receiving either tofacitinib or other approved treatments for their condition based on their doctor's decision.

To join the trial, patients must have active UC and meet specific health criteria, such as being stable on their current medications for at least three months. Women of childbearing age must use reliable birth control methods. Participants will be closely monitored throughout the study, and they can expect regular check-ins with the research team to ensure their safety and gather important information about their health. This trial could provide valuable insights into the safety of tofacitinib for patients with ulcerative colitis, particularly regarding the risk of blood clots.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. Intrauterine device (IUD).
• • 2. Bilateral tubal occlusion.
• • 3. Couple with vasectomy.
• • 4. 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:
• • 1. Intrauterine device (IUD).
• • 2. Bilateral tubal occlusion.
• • 3. Couple with vasectomy.
• • 4. 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:
• • 1. Intrauterine device (IUD).
• • 2. Bilateral tubal occlusion.
• • 3. Couple with vasectomy.
• • 4. 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:
• • 1. Intrauterine device (IUD).
• • 2. Bilateral tubal occlusion.
• • 3. Couple with vasectomy.
• • 4. Sexual abstinence.
• Exclusion Criteria:
• • 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.