Tofacitinib's effects on blood clotting and ulcerative colitis

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

This study is testing if tofacitinib can safely improve blood clotting and help people with ulcerative colitis who haven't responded to other treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (Academic / other)
• Drugs / interventions: infliximab, adalimumab, golimumab, tofacitinib, vedolizumab, baricitinib, ruxolitinib, upadacitinib, pefacitinib, filgotinib, pacritinib
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT05313620 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of tofacitinib on coagulation and platelet function in patients with ulcerative colitis (UC) and its potential role in thromboembolic events. Patients will receive either tofacitinib or anti-TNFα treatments based on the investigator's discretion, without random assignment. The study aims to gather data on the safety and efficacy of tofacitinib in a real-world clinical setting, focusing on patients who are refractory to other treatments. The trial is conducted at a single center, the Hospital Universitario de La Princesa in Madrid.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old with a confirmed diagnosis of ulcerative colitis who have had stable previous treatments for at least three months.

Not a fit: Patients without ulcerative colitis or those with other inflammatory, allergic, malignant, or autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for patients with ulcerative colitis and reduce the risk of thromboembolic events.

How similar studies have performed: While there have been studies on the effects of tofacitinib in ulcerative colitis, this specific focus on coagulation and thromboembolic events is relatively novel.

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.

Where this trial is running

Madrid, Madrid

• Hospital Universitario de La Princesa — Madrid, Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Sandra Hermida

Conditions Ulcerative Colitis; Thromboembolism; ulcerative colitis; Tromboembolism; Coagulation; Platelet Function; Tofacitinib; JAK inhibitors