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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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Page 1 of 1 (1 locations)

1

Hospital Universitario de La Princesa

Madrid, Madrid, Spain, 28006