SISTER –Subcutaneous: Non-Interventional Study for Tysabri Patient Preference – Experience from Real World - DE-TYS-11923

Biogen GmbH0 个研究点目标入组 318 人开始时间: 2021年9月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Ability of the patient to understand the purpose of the data collection and to provide signed and dated informed consent in participation and collection and processing of personal data (health information) in a pseudonymous form.
•At least 18 years of age at enrollment.
•Diagnosis of highly active RRMS (RRMS diagnosis according to McDonald criteria (2018) and initiating natalizumab treatment (new starters) is indicated based on current SmPC.
•In RRMS patients who are already on intravenous natalizumab therapy, continued treatment must be indicated based on current SmPC.
•Natalizumab treatment and administration in accordance with the current SmPC.
•Patients who start natalizumab therapy (IV starters or SC starters) are allowed a maximum of three applications of natalizumab prior to study inclusion. Patients who switch from IV to SC administration route (Switchers) are allowed a maximum of three subcutaneous applications of natalizumab prior to study inclusion (the interval between the last IV and the first SC application must not exceed 8 weeks).
•Decision to start/continue natalizumab treatment and choice of administration route has been made prior to and independently of patient’s study participation.
•The special warnings and precautions for use listed in the current SmPC of Tysabri® (natalizumab) should be considered for patient selection and treatment.

•Patients with any of the following characteristics will be excluded from the data collection within this non-interventional study:
•Progressive forms of MS
•Contraindication to natalizumab treatment according to current Tysabri (natalizumab) SmPC
•Participation in any interventional clinical trial

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