Experimental protocols for investigating immunogenicity to biopharmaceuticals in patients with immune mediated inflammatory disease (IMIDs) - Cross-sectional ABIRISK project

Academisch Medisch Centrum0 个研究点目标入组 108 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Male and female patients of more than 18 years old diagnosed with an IMID
•- Patients being treated in the usual manner in accordance with the terms of the marketing authorization and independently from entry into this study:
•* Patients treated with Anti TNF therapy for over three months i.e. adalimumab, etanercept or infliximab in first line independently from inclusion into study or,
•* Patients treated with Rituximab after failure with anti-TNF therapy or other biotherapy or given in first line or
•* Patients treated with Tocilmumab after failure with anti-TNF therapy or other biotherapy or given in first line
•- Having given written informed consent prior to undertaking any study-related procedures.
•- Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.

•- Under any administrative or legal supervision.
•- Conditions/situations such as:
•* Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
•* Impossibility to meet specific protocol requirements (e.g. blood sampling)
•* Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
•* Uncooperative or any condition that could make the patient potentially non-compliant to the study procedures
•- Pregnant or breast-feeding women, currently or in the last three months prior to inclusion.
•- Patients who have been vaccinated in the last three months prior to inclusion.

发起方