Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study - SILVER-study

Amsterdam UMC0 个研究点目标入组 40 人开始时间: 2022年9月29日最近更新: 2023年1月9日

试验速览

暂无简介。

•?Age 18 or older;
•?Diagnosis of CD or UC;
•?Clinical and biochemical remission, all three criteria below need to be fulfilled prior to enrolment:
•?Absence of active inflammatory intestinal symptoms, as judged by both patient and physician;
•?FCP <250 µg/g and CRP <5 mg/L;
•?HBI <5 (CD) or SCCAI <4 (UC).
•?Steroid-free remission for =6 months whilst being treated with SC vedolizumab at a stable dose (108 mg every 2 weeks);
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•?Absence of written informed consent;
•?Presence of anti-drug antibodies against vedolizumab;
•?Concomitant oral glucocorticosteroid usage;
•?Imminent need for IBD-related surgery as judged by the treating clinician;
•?Actively draining peri-anal fistula;
•?Patients with short bowel syndrome, an ostomy or a symptomatic stricture;
•?Active participation in another interventional trial;
•?Pregnancy or lactation;
•?Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness);
•?Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy.

发起方

Amsterdam UMC