Multiple sclerosis patients in relapse and remission form MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: ozanimod cloridrato
Product Code: [ozanimod cloridrato]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
CAS Number: 1618636-37-5
Current Sponsor code: Ozanimod
Concentra
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For RRMS patients: - Age between 18 and 55 years (in line with phase III RCTs); - A diagnosis of RRMS according to the 2017 Revisions of the McDonald criteria;58 - RRMS patients starting treatment with ozanimod, according to European Medicines Agency (EMA) and Italian Medicine Agency (AIFA) criteria (if available at the moment of study initiation); - EDSS score =5.0 (in line with phase III RCTs); - Planned vaccinations completed prior to enrollment; - Provide informed consent signed for participation in the trial; - Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.* * NOTE where the use of effective contraception is a protocol requirement a section on Contraception and Pregnancy should be added to the safety reporting section with corresponding information in the Participant Information Sheet. For HC subjects: - Age between 18 and 55 years; - Provide informed consent signed for participation in the trial. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For RRMS patients: - Age 55 years; - Contraindications to ozanimod treatment as reported by EMA and AIFA (if available) recommendations; - Major medical illnesses including neurological (apart MS), cardiac, renal, hepatic, orthopedic, or rheumatologic disorders; - History of psychiatric or mood disorders, or of drug or alcohol abuse; - MRI contraindications, including claustrophobia, pregnancy, breastfeeding or metal implants; - One or more symptomatic treatment(s) (e.g., antidepressants, myorelaxants, psychoactive drugs) started/modified within the 3 months before ozanimod start; - The participant has previously participated in any clinical trial of ozanimod; - The participant is accommodated in an institution because of a regulatory or legal order, is a prisoner, or is legally institutionalized; - Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. (positive urine ß-subunit of human chorionic gonadotropin [HCG]). For HC subjects: - Age 55 years; - Major medical illnesses including neurological, cardiac, renal, hepatic, orthopedic, or rheumatologic disorders; - History of psychiatric or mood disorders, or of drug or alcohol abuse; - MRI contraindications; - Female participant who is pregnant, lactating or planning pregnancy during the course of the trial (positive urine ß-subunit of HCG).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effects of ozanimod in RRMS patients in limiting the progression of brain neurodegenerative phenomena over the course of 2 years.;Secondary Objective: The secondary objectives of this study are to evaluate the effects of ozanimod treatment over the course of 2 years (at month 6, year 1 and year 2) in RRMS patients in the following terms: 1. Preventing further demyelination and tissue damage and promoting remyelination and tissue recovery; 2. Reducing the burden of chronic active lesions; 3. The number of clinical relapses and the occurrence of disability progression/improvement; 4. The longitudinal changes of cognitive performances, fatigue, depression, and QoL; 5. The longitudinal changes of conventional MRI measures of disease activity; 6. The longitudinal evolution of neuro-axonal damage; 7. The associations between clinical, neuropsychological, MRI, and pNfL measures.;Primary end point(s): The primary endpoints of this study are to assess, in RRMS patients treated with ozanimod, the changes from baseline over 2 years of: •Global brain atrophy (i.e., percent brain volume change [PBVC]); •Regional GM volume; •Regional WM volume; •Thalamic volume; •Cortical volume.;Timepoint(s) of evaluation of this end point: month 6, year 1 and year 2 after the start of treatment with ozanimod | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 4. Changes from baseline in cognitive profile (Brief Repeatable Battery of Neuropsychological Tests), in fatigue (Modified Fatigue Impact Scale [MFIS]), in depression (Montgomery and Asberg Depression Rating Scale [MADRS]), and in quality of life ( MSQOL-54);; 1. 2-year changes from baseline in magnetization transfer ratio values ¿¿in white matter lesions, gadolinium-enhancing lesions, apparently normal white matter, and gray matter from baseline across different time points at follow-up up;; 2. The number, volume and proportions of lesions defined or not as 'slowly-evolving lesions' and the evolution of their magnetization transfer ratio and T1 signal intensity values ¿¿to explore the dynamics of myelin content and axonal density within these lesions;; 3. Annualized relapse rate, worsening / improvement in Expanded Disability Status Scale (EDSS) score, change in Multiple Sclerosis Functional Compostive (MSFC) score, proportions of patients with relapsing multiple sclerosis and remissions without clinical relapses;; 5. Number of new / enlarged T2 hyperintense lesions on MRI of the brain; number of gadolinium-enhancing lesions; single combined activity; percentage of patients with relapse and remission multiple sclerosis without new / enlarged and / or gadolinium-enhancing T2 hyperintense lesions; 6. Longitudinal variations in plasma levels of neurofilament light chains;; 6. Longitudinal variations in plasma levels of neurofilament light chains;; 7. Correlation between MRI measures, plasma levels of neurofilament light chains and clinical measures of disability, cognitive impairment, fatigue, depression and quality of life.;Timepoint(s) of evaluation of this end point: month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 after starting treatment with ozanimod.; month 6, year 1 year 2 | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Ospedale San Raffaele
Outcome results
None listed