Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients

Prior treatment

• Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
• Use of other experimental or investigational drugs
• Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while receiving ofatumumab and for 6 months after the last administration. The requirements for contraception for the comparators should also be taken into consideration according to their SmPC.
• Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
• Patients with neurologic/psychiatric disorders prior to first study drug administration • Score “yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (CSSRS) if this ideation occurred in the past 6 months OR • “yes” on any item of the Suicidal Behavior section, except for the “Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior section) if this behavior occurred in the past 2 years.

Other illness

• Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
• Positive results at Screening for serological markers for hepatitis B and C
• Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate or comply with the study procedures
• Conditions or treatments that may impact the safety of the patient
• History of hypersensitivity to the study drug or any of the excipients or to drugs of similar chemical classes
• Patients with an active infection until the infection is resolved. Where local regulation requires it, SARS-Cov-19 must be ruled out by the PCR test.
• Patients with severe hypoproteinemia e.g. in nephrotic syndrome

Lab values

• Abnormal laboratory values as confirmed by the central laboratory prior to first study drug administration

Other

• Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
• Progressive MS phenotypes
• Relapse between Screening and Baseline visits
• Pregnancy or breastfeeding
• Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator

• Written informed consent obtained before any assessment
• Neurologically stable within 1 month prior to first study drug administration
• Male/female patients, 18 through 55 (inclusive) years of age.
• Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al. 2018).
• Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014.
• Treatment Naïve patients, ≤ 5 years since first MS symptom.
• EDSS score: 0–4.0 (inclusive).
• Patient must be suitable to be treated with one of first line self-administered DMT physician’s choice (glatiramer acetate, IFNs, teriflunomide or DMF, according to EMA SmPC) or ofatumumab depending on randomization and physician’s choice.
• At least 1 relapse or 1 Gd+ enhanced lesion on T1 in 1 year prior to Screening.
• Able to obtain MRI assessment.