relapsing remitting multiple Sclerosis MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Zeposia
Product Name: Ozanimod
Product Code: [NA]
Pharmaceutical Form: Capsule, hard
CAS Number: 1306760-87-1
Current Sponsor code: NA
Concentration unit: µg microgram(s)
Concentration typ
Sponsors
I.R.C.C.S. FONDAZIONE S.LUCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of MS accordingly to 2017 revised McDonald criteria; 2) Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.); 3) Age between 18 and 45 years; 4) EDSS score from 0 to 4; 5) Signature and date of written ICF prior to entering 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Ongoing immunomodulatory or immunosuppressive treatment; 2) Other autoimmune comorbidities (i.e. antiphospolipid syndrome); 3) Treatment with steroids in the last 30 days before enrollment; 4) Acute inflammatory status not MS related (i.e. bacterial or viral infections) in the previous 30 days; 5) Patients unable to read and understand the documents of the study. 6) Participation in any interventional clinical trials or compassionate use programs 7) Contraindications and “not-recommendations” reported in SmPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To use this multidimensional integrated approach to efficiently monitor multiple clinical parameters in MS patients during Ozanimod treatment in order to understand how neurodegeneration correlates with immunological parameters of neuroinflammation in RRMS patients over a 12-months observation period and to verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration;Secondary Objective: Na;Primary end point(s): To evaluate the innate immune mediated inflammation in MS patients and to correlate it with the cognitive reserve and with serum NFL levels before and after Ozanimod treatment;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To observe the effect of Ozanimod on innate and adaptive immune cells in terms of activation, immune modulation and cell proliferation at the different time points. • To compare, through deep immune profiling, specific immune signatures between NEDA (no evident disease activity) and EDA (evident disease activity) patients; • To correlate specific immune profiles with clinical parameters such as lymphocyte counts, serum NFL, EEG connectivity patterns and/or MRI findings and to measure the effect of Ozanimod on these parameters;;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactClinical trial center
Fondazione Santa Lucia IRCCS
Outcome results
None listed