A multicentric randomized PRAGmatic trial to compare the effectiveness of fingolimod versus dimethyl-fumarate on patient overall disease experience in relapsing remitting Multiple Sclerosis: novel data to inform decision-makers – (PRAG-MS) - PRAG-MS

FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA0 个研究点目标入组 1,360 人开始时间: 2021年9月30日最近更新: 2021年10月8日

试验速览

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•adult patients diagnosed with relapsing remitting multiple sclerosis who are eligible to both fingolimod and dimethyl-fumarate treatment as for local authority indications and clinical judgement could be enrolled in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 900
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•any FTY/DMF contraindication, as for authorized indications or clinical judgment
•present immunodeficiency syndrome (primary or secondary immune deficiency)
•severe chronic active infections or acute infections not resolved at the time of the enrolment
•evidence of active tuberculosis (TB)
•history of either untreated or inadequately treated latent TB infection. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised subjects.
•Progressive Multifocal Leukoencephalopathy, even if only suspected
•active malignancies
•severe liver impairment (Child-Pugh class C)
•hypersensitivity to the active substances or to any of the excipients
•Pregnancy or breastfeeding.

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