ozanimod for Relapsing-remitting multiple sclerosis

Inclusion criteria

• {"criterion_text":"- For RRMS patients: Age between 18 and 55 years (in line with phase III RCTs);"}
• {"criterion_text":"- For RRMS patients:A diagnosis of RRMS according to the 2017 Revisions of the McDonald criteria;"}
• {"criterion_text":"- For RRMS patients: 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);"}
• {"criterion_text":"- For RRMS patients: EDSS score =5.0 (in line with phase III RCTs);"}
• {"criterion_text":"- For RRMS patients: Planned vaccinations completed prior to enrollment;"}
• {"criterion_text":"- For RRMS patients: Provide informed consent signed for participation in the trial;"}
• {"criterion_text":"- For RRMS patients: 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."}
• {"criterion_text":"- For HC subjects: Age between 18 and 55 years;"}
• {"criterion_text":"- For HC subjects: Provide informed consent signed for participation in the trial."}

Exclusion criteria

• {"criterion_text":"- For RRMS patients: Age <18 or >55 years;"}
• {"criterion_text":"- For HC subjects: Age <18 or >55 years;"}
• {"criterion_text":"- For HC subjects: Major medical illnesses including neurological, cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;"}
• {"criterion_text":"- For HC subjects: History of psychiatric or mood disorders, or of drug or alcohol abuse;"}
• {"criterion_text":"- For HC subjects: MRI contraindications;"}
• {"criterion_text":"- For HC subject: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial (positive urine ß-subunit of HCG)."}
• {"criterion_text":"- For RRMS patients: Contraindications to ozanimod treatment as reported by EMA and AIFA (if available) recommendations;"}
• {"criterion_text":"- For RRMS patients: Major medical illnesses including neurological (apart MS), cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;"}
• {"criterion_text":"- For RRMS patients: History of psychiatric or mood disorders, or of drug or alcohol abuse;"}
• {"criterion_text":"- For RRMS patients: MRI contraindications, including claustrophobia, pregnancy, breastfeeding or metal implants;"}
• {"criterion_text":"- For RRMS patients: One or more symptomatic treatment(s) (e.g., antidepressants, myorelaxants, psychoactive drugs) started/modified within the 3 months before ozanimod start;"}
• {"criterion_text":"- For RRMS patients: The participant has previously participated in any clinical trial of ozanimod;"}
• {"criterion_text":"- For RRMS patients: The participant is accommodated in an institution because of a regulatory or legal order, is a prisoner, or is legally institutionalized;"}
• {"criterion_text":"- For RRMS patients: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. (positive urine ß-subunit of human chorionic gonadotropin [HCG])."}

Primary endpoints

• {"endpoint_text":"- Global brain atrophy (i.e., percent brain volume change [PBVC]);\n- Regional GM volume;\n- Regional WM volume;\n- Thalamic volume;\n- Cortical volume.","definition_or_measurement_approach":"Assess changes from baseline over 2 years in RRMS patients treated with ozanimod (changes from baseline over 2 years; Global brain atrophy measured as percent brain volume change [PBVC]; regional and structure volumes measured as changes from baseline)."}

Italy

Earliest CTIS Part Ii Submission Date

12-06-2024

Latest Decision Or Authorization Date

01-07-2024

Processing Time Days

19

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy