Symptom improvement of ulcerative colitis after an induction dose of ustekinumab in Japanese clinical practice, measured using patient-reported outcomes - Sirius study

Janssen Pharmaceutical K.K0 个研究点目标入组 136 人开始时间: 2021年3月31日最近更新: 2023年10月17日

试验速览

暂无简介。

•1.has ever previously received ustekinumab (including clinical trial use) 2. based on physician judgement has i) severe extensive colitis and is at imminent risk of colectomy OR ii) a stoma or history of a fistula OR iii) previously had extensive colonic resection (e.g., less than 30 cm of colon remaining) OR iv) current fulminant colitis OR v) currently hospitalized for worsening of UC-related symptoms (Not excluded if the reason for hospitalization is first dose of ustekinumab ). 3. are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (e.g. Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) 4. received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point 5. currently enrolled in an interventional study or another Janssen-sponsored observational study (including post-marketing surveillance)

发起方