engthening Adalimumab Dosing Interval in IBD patients in long termremission, the LADI study

Erasmus MC0 个研究点开始时间: 2014年5月28日最近更新: 2015年3月16日

适应症

试验速览

暂无简介。

•Age 18 or older
•Written informed consent.
•Previous diagnosis of ileocolonic Crohn's disease or ulcerative colitis In sustained clinical remission for at least 6 months whilst being treated with adalimumab
•Adalimumab dosed at 40mg, once every 2 weeks
•Full clinical response and disease control, defined as
•-Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
•-Fecal calprotectin < 200 µg/g and CRP within normal range
•Permitted concomitant therapy: aminosalicylates, azathioprine, 6- mercatopurine and methotrexate at stable dose for 12 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 130
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Concomitant corticosteroid usage
•Imminent need for IBD-related surgery
•Actively draining perianal fistula
•Pregnancy or lactation
•Other significant medical illness that might interfere with this study (such as current malignancy, immunodeficiency syndromes and psychiatric illness)

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