EFFECT OF TOFACITINIB ON COAGULATIO

Phase 1

• Conditions: ulcerative colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; MedDRA version: 20.0Level: PTClassification code 10009790Term: Coagulation timeSystem Organ Class: 10022891 - Investigations; MedDRA version: 21.0Level: PTClassification code 10061684Term: Platelet function testSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2021-002211-65-ES
• Lead Sponsor: Fundación Española de Gastroenterología

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-11
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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 potential who use methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
intrauterine device (IUD)
bilateral tubal occlusion
vasectomised partner
sexual abstinence

Or women of childbearing potential who use a combination of male condom with either cap, diaphragm or sponge with spermicide

INDIVIDUALS WITHOUT UC:
- Over 18 years old.
- Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases.
- Women of childbearing potential who use methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
intrauterine device (IUD)
bilateral tubal occlusion
vasectomised partner
sexual abstinence

Or women of childbearing potential who use a combination of male condom with either cap, diaphragm or sponge with spermicide

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-TNFa (infliximab, adalimumab or golimumab) o tofacitinib.
- Be the first received JAK-inhibitor or anti-TNFa with a given mechanism of action and 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-TNFa and that they are maintained at a stable dose for the duration of the study
-Women of childbearing potential who use methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
intrauterine device (IUD)
bilateral tubal occlusion
vasectomised partner
sexual abstinence

Or women of childbearing potential who use a combination of male condom with either cap, diaphragm or sponge with spermicide

INDIVIDUALS WITHOUT UC:
- Over 18 years old.
- Subjects not diagnosed with UC, or other inflammatory, allergic, malignant or autoimmune diseases.
- Women of childbearing potential who use methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
intrauterine device (IUD)
bilateral tubal occlusion
vasectomised partner
sexual abstinence

Or women of childbearing potential who use a combination of male condom with either cap, diaphragm or sponge with spermicide
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.
- Abdominal surgery in the last 6 months.
- Colectomy.
- Active infection with hepatitis B, C or HIV virus.
- Indication of anti-TNFa or JAK-inhibitors treatment for a cause other than UC.
- Have previously received a drug with the same mechanism of action (anti-TNFa 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified