engthening Adalimumab Dosing Interval in quiescent Crohn’s disease patients: the LADI study.

Radboud University Medical Centre0 个研究点开始时间: 2016年12月8日最近更新: 2017年4月10日

适应症

试验速览

暂无简介。

•Age 18 or older
•Diagnosis of colonic and/or distal ileal CD
•Sustained steroid-free clinical remission for >12 months whilst being treated with adalimumab at a stable dose
•Adalimumab dosed at 40 mg every 2 weeks
•Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment:
•-Absence of active inflammatory intestinal or extra-intestinal symptoms, as judged by both patient and physician
•-Fecal calprotectin (FC) < 150 µg/g and CRP <5 mg/L
•-Harvey Bradshaw Index (HBI) <5
•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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•Absence of written informed consent
•Concomitant corticosteroid usage
•Need for IBD-related surgery
•Actively draining peri-anal fistula
•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

Radboud University Medical Centre