2024-518577-34-00招募中4 期
(A)nalysis of immunological (VA)riables in ex vivo (T)ofacitinib-treated human biopsies from (A)ctive ulcerative colitis patients to predict clinical (R)esponse (the AVATAR study).
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Immunological characterization
研究概览
简要总结
Research of predictive factors for response to Tofacitinib therapy in patients with ulcerative rectal 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
- 否
入选标准
- •Provided written informed consent.
- •>18 years of age
- •Confirmed diagnosis of ulcerative colitis according to international guidelines (ECCO).
- •Patients with moderately-to-severely active disease, as defined as a Mayo score of 6-12, with a rectal bleeding subscore of 1 to
- •Endoscopic Mayo subscore of 2-
- •Patients who had failure or intolerant to at least one of the following agents: oral or intravenous glucocorticoids, azathioprine, 6-mercaptopurine, infliximab, golimumab or adalimumab.
- •Because the effects of Tofacitinib on pregnancy are not fully understood, women in childbearing age have to avoid pregnancy. Therefore the above cited patients have to use a suitable contraceptive method such as diaphragm, spiral or contraceptive pill before entering the study, for its entire duration and for 15 weeks after the suspension of the aforementioned drug
排除标准
- •Clinical findings suggestive of Crohn’s disease.
- •Ulcerative colitis limited to the distal 15 cm of colon.
- •Clinical signs of fulminant colitis, toxic megacolon, or indeterminate, microscopic, ischemic, or infectious colitis.
- •Patients at high risk of thromboembolism: 1) Patients with heart failure 2) Patients with inherited coagulation disorders 3) Patients who have history of venous thromboembolism, either deep venous thrombosis or pulmonary embolism. 4) Patients who use combined hormonal contraceptives or hormone replacement therapy. 5) Patients with malignancy 6) Patients undergoing major surgery
- •Known hypersensitivity/intolerance to tofacitinib (Xeljanz).
- •Presence of Child-Pugh class C hepatic impairment or eGFR<30 ml/min.
- •Chronic HIV, HBV, HCV infections (excluding patients with HCV infection treated with anti-viral agents in which serum HCV-RNA is not detectable).
- •Active TB or history of latent TB that has not been adequately treated, history of symptomatic herpes zoster (HZV) or any history of disseminated herpes simples (HSV) infections. Active opportunistic, clinically significant infections.
- •History of malignancy in the last 5 years.
- •Pregnant or lactating females.
- •Females of reproductive potential who are unwilling to abide by protocol specified contraceptive methods 8as defined by Appendix 1 in the Study protocol)
结局指标
主要结局
Immunological characterization
Immunological characterization
次要结局
未报告次要终点
研究者
Massimo Claudio Fantini
Scientific
Universita' Degli Studi Di Roma Tor Vergata
研究点 (2)
Loading locations...
相似试验
招募中
4 期
Effect of Tofacitinib on coagulation and platelet function, and its role in thromboembolic eventsulcerative colitis2024-518434-83-01Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa60
招募中
4 期
Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative ColitisNCT07258771Berinstein, Jeffrey110
进行中（未招募）
不适用
Tofacitinib Registry of patients with ulcerative colitis in GermanyK51Ulcerative colitisDRKS00017740CED Service GmbH50
招募中
3 期
EvAluation of the efficacy of MaaT013 as salvage theRapy in acute GVHD patiEntS with gastrointestinal involvement, refractory to ruxolitinib; a multi-center open-label phase III trial.2024-513023-17-00MaaT PHARMA, MaaT PHARMA73
已完成
不适用
Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool SamplesUlcerative ColitisNCT03663400NYU Langone Health47