Comparison of Vedolizumab treatment to Adalimumab dose intensification in Crohn’s disease patients with loss of response or biomarker activity to Adalimumab on first line with therapeutic drug concentration: A randomized, multicentre, controlled VEDIAN trial. - 23CH214

Centre Hospitalier Universitaire De Saint Etienne0 个研究点目标入组 220 人开始时间: 2023年10月24日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Major patient and having given consent to participate in the study, Patients with Crohn's disease who have responded primarly to Adalimumab princeps or similar bio with loss of response to Adalimumab (40 mg every two weeks) with therapeutically adequate levels of ADA (> 7.5 µg/mL)., Patient affiliated to or entitled under a social security scheme

•Pregnant woman, Patients receiving enteral nutrition, Patient under legal protection or unable to give consent, Hemorrhagic rectocolitis or indeterminate colitis, Patients treated with concomitant immunosuppressive agents, Patient treated with an optimized dose of adalimumab, Primary non-responder to Adalimumab, Patient previously treated with infliximab or ustekinumab before adalimumab, Severe relapse defined by CDAI > 330, Patient with anoperineal Crohn's disease, Crohn's disease patient with transient or permanent stoma, Patient unable to perform MRI or VCE or ileocoloscopy or ultrasound less than one month before inclusion, Patients on corticosteroid therapy, Previous or current use of vedolizumab or ustekinumab for Crohn's disease or participation in a biological study, Concomitant use of immunomodulators, History of cancer, History of human immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system (CNS) demyelinating disease (including myelitis), neurological symptoms suggestive of demyelinating disease, chronic recurrent infection, active tuberculosis (received or untreated), severe infections such as sepsis and opportunistic infections., Patient with ileoanal pouchitis or ileorectal anastomosis, Patient with short small bowel syndrome as determined by investigator, Patients receiving total parenteral nutrition (TPN).

发起方