EUCTR2021-002211-65-ES进行中（未招募）1 期
EFFECT OF TOFACITINIB ON COAGULATION AND PLATELET FUNCTION, AND ITS ROLE IN THROMBOEMBOLIC EVENTS
Fundación Española de Gastroenterología0 个研究点目标入组 60 人开始时间: 2021年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
- •- 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.
- •- 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.
- •- 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.
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