Retreatment with subcutaneous Infliximab in patients with refractory Crohn’s disease - Re-Introduce

niversitätsklinikum Freiburg0 个研究点目标入组 30 人开始时间: 2024年3月5日最近更新: 2024年8月19日

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•CD patients with previous documented loss of response to anti-TNF therapy (i.e. infliximab or adalimumab), in which retreatment is considered to be clinically useful by the treating physician and who are refractory or intolerant to conventional therapies and/or at least one other licensed class of biological therapy (including Ustekinumab or Vedolizumab)
•- age range 18-70 years
•- CD activity (stool calprotectin > 250 mg/kg and/or C-reactive protein > 5 mg/l) AND active disease as evidenced by PRO-2 [average daily abdominal pain =2 and/or stool frequency =4]).

•Documented allergic reactions to infliximab in the past.
•Clinically significant stenosis documented by abdominal pain and small bowel distention > 3 cm in a non-affected part of the small intestine proximal to the stenosis.
•Absence of bowel wall enhancement in contrast enhanced MRI or bowel ultrasound.
•Severe concomitant diseases considered as contraindication for the use of anti TNF antibodies as stated in the medication’s license, such as renal insufficiency, heart failure, chronic liver disease, chronic uncontrolled infections, myelodysplasia, malignant diseases.
•Complications of Crohn’s disease at high risk to require surgery (e.g. abscess, complicated fistula) or recommendation for surgery by the center’s interdisciplinary IBD board.
•Evidence of latent infections as stated in the license of anti-TNF antibodies (documented exclusion of latent tuberculosis, e.g., by negative interferon gamma release assay such as Quantiferon-test, not older than 6 months; exclusion of chronic Hepatitis B virus infection within 24 months prior to inclusion).

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