Effect of Tofacitinib on coagulation and platelet function, and its role in thromboembolic events
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation
研究概览
简要总结
Evaluate the effect of tofacitinib on platelet function and coagulation in patients with ulcerative colitis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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).
- •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.
排除标准
- •Under 18 years old.
- •Pregnancy or lactation.
- •Alcohol or drug abuse.
- •Active infection with hepatitis B, C or HIV virus.
- •Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC.
- •abdominal surgery in the last 6 months
- •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.
- •Immune-mediated disease.
- •Neoplasm or active infection.
结局指标
主要结局
Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation
Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation
次要结局
- Endoscopic activity will be evaluated by the Mayo endoscopic sub-score; endoscopic activity will be considered as ≥ 2.
- Endoscopic response will be defined as a decrease of ≥ 1 point in the Mayo endoscopic sub-score 3 months after starting treatment.
- Endoscopic remission will be defined as an endoscopic subscore ≤1, 3 months after starting treatment.
研究者
Ana Garre
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa