A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis - IASO

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge0 个研究点目标入组 214 人开始时间: 2017年8月17日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Patients aged 16-80 inclusive
•- Have given written informed consent to participate
•- Hospitalised patients with clinically confirmed or suspected acute severe ulcerative colitis and a Modified Truelove Witts Severity Index score =11
•- Requirement for treatment with IV corticosteroids in the judgement of the treating clinician, with the possibility to receive a first dose of IMP within 36 hours of commencement of IV corticosteroids
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 4
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Pregnant or breast-feeding women
•- Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
•- History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
•- Moderate or severe renal impairment (eGFR <50ml/minute)
•- Neutropenia (neutrophil count <1.5x109/l)
•- Previous treatment with anakinra for any indication
•- Evidence (from blood cultures etc) or clinical suspicion of systemic infection
•- Current or previous cytomegalovirus (CMV) infection requiring treatment with anti-viral agents
•- Current treatment with anti-TNF-a therapy or anti-TNF-a discontinuation within previous 16 weeks
•- A history of pulmonary TB infection
•- History of malignancy (with the exception of non-melanoma skin cancer) or colonic dysplasia
•- Receipt of another IMP as part of a CTIMP within the previous 16 weeks

发起方

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge