A multicentric, international study in order to compare the effectiveness of fingolimod versus dimethyl-fumarate on patients with Multiple Sclerosis.

Phase 1

• Conditions: relapsing-remitting multiple sclerosis; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000559-26-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-30
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1360

Inclusion Criteria

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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified