Clinical Validation of a Point of Care (POC) Test for the Measurement of Infliximab (IFX) or Adalimumab (ADL) Levels in the Serum of Inflammatory Bowel Disease (IBD) Patients

ProciseDx0 个研究点目标入组 320 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•1.Adult (=16 years old) Males and females with either CD or UC.
•2.Patients must have a confirmed diagnosis of CD or UC based on results of a complete medical evaluation and assessment by a physician specialized in inflammatory bowel disease.
•3.Patients must be undergoing maintenance phase IFX or ADL therapy at the time of the first blood collection used for the current study
•4.Patients must have at least 24 months of follow up after the baseline sample.
•5.Written informed consent must be provided.

•1.Patients not undergoing maintenance phase IFX, ADL or biosimilar therapy at time of baseline sample collection.
•2.Patients not diagnosed with either CD or UC.
•3.Receipt of any blood products within 3 months prior to the baseline sample collection
•4.Participation in a clinical trial at the baseline sample collection or within the 8 weeks prior to the baseline sample collection.

发起方

ProciseDx