Subcutaneous Infliximab After A Previous Intravenous Dose Optimization - BIRD2023001

Belgian IBD Research and Development0 个研究点目标入组 275 人开始时间: 2023年12月29日最近更新: 2024年7月22日

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•Patients with a previously documented CD, UC, IBDU diagnosis confirmed by clinical , endoscopic, histological, and/or radiological criteria., Males and females =18 years old, Patients must be in steroid-free clinical remission at Screening defined as a rectal bleeding score of 0 and a stool frequency score of =1 for patients with UC / IBDU, or an average daily abdominal pain score =1 and a liquid stool frequency score =2.8 for patients with CD (based on the 3 days before the screening visit, excluding the day of or the day before an eventual endoscopy with bowel preparation) and this without the need for any type of steroids in the previous eight weeks., Patients must be in biological remission at screening defined as a CRP <10 mg/L and a fecal calprotectin <250 µg/g., Patients receiving IV infliximab for at least 26 consecutive weeks., Patients receiving a stable IV dosing schedule for at least 20 weeks., Patients receiving an average IV infliximab per eight weeks based on the two most recent IV administrations of more than 8 mg/kg, but not more than 20 mg/kg., Patients who speak and read fluently Dutch, French or English., Patients who is able to voluntary give their written informed consent.

•Male or female < 18 years, Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy (transient or permanent), Patients participating in an interventional clinical trial with an Investigational Medicinal Product (IMP) or device., Patients previously treated with subcutaneous infliximab., Patients with active perianal fistulizing disease., Patients with microscopic colitis.

发起方

Belgian IBD Research and Development