Prospective study to validate a multidimensional treatment decision score (DIFUTURE-MS-TDS) which predicts the 24 month outcome in untreated patients with Clinically Isolated Syndrome and early Relapsing-Remitting Multiple Sclerosis under specific treatment options - ProVal-MS

eurologische Klinik, Klinikum rechts der Isar, TU München0 个研究点目标入组 500 人开始时间: 2018年12月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•I 1. Male and female patients between the age of 18 and 60 years with CIS or RR-MS according to the valid 2017 McDonald criteria diagnosed within the last two years and before the initiation of immunotherapy
•I 2. Having given written informed consent prior to undertaking any study-related procedures

•Patients who have met all the above inclusion criteria will be screened for the following exclusion criteria:
•E 01.Under any administrative or legal supervision or unable to give informed consent.
•E 02.Previous treatment with DMT drugs (including corticosteroid therapy of relapses if given less than four weeks prior baseline)
•E 03.Conditions/situations such as:
•oPatients with conditions/concomitant diseases making them non-evaluable for the primary endpoint (e.g. pre-existing neurological disease, systemic autoimmune diseases)
•o A requirement for concomitant treatment that could bias primary evaluation
•o The inability to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the informed consent form)
•o The patient is directly involved in the conduct of the protocol: the investigator or a subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof
•o Is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures
•o Pregnant or breast-feeding women

发起方

eurologische Klinik, Klinikum rechts der Isar, TU München