Multiple Sclerosis MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent obtained before any assessment • Male/female patients, 18 through 55 (inclusive) years of age • Diagnosis of MS according to the 2017 revised McDonald criteria • 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, DMF, or diroximel fumarate, 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. • Neurologically stable within 1 month prior to first study drug administration Please see protocol for complete detailed list of inclusion criteria 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 186 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Diseases other than multiple sclerosis responsible for the clinical or MRI presentation • Progressive MS phenotypes: Patients with primary progressive MS or SPMS • Use of other experimental or investigational drugs • 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 • Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) 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 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 neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML •Positive results at Screening for serological markers for hepatitis B and C • Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration • 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 • Abnormal laboratory values prior to first study drug administration • Patients with severe hypoproteinemia e.g. in nephrotic syndrome • Patients with any of the following 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 • History of hypersensitivity to the study drug or any of the excipients or to drugs of similar chemical classes Please see protocol for complete detailed list of exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of ofatumumab vs first line physician’s choice DMTs for self-administration in newly diagnosed/ treatment naïve RMS patient population at Month 15 ;Secondary Objective: - Evaluate the efficacy to therapy of ofatumumab vs first line self-administered DMTs (physician’s choice) in newly diagnosed/naïve-treated RMS patient population - Evaluate the safety and tolerability of ofatumumab vs first line self-administered DMTs (physician’s choice) in newly diagnosed/naïve-treated RMS patient population;Primary end point(s): • NEDA-3 status (yes or no) NEDA-3 is defined as: 1. Absence of confirmed clinical relapse 2. Absence of new MRI activity (Gd+ T1 lesion or new/enlarged T2 lesion) with MRI re-baselined at Month 3 3. Absence of 3-month confirmed disability worsening ;Timepoint(s) of evaluation of this end point: At Month 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of relapses up to Month 15/ EOS • Annual Relapse Rate (ARR) • Mean time to first relapse • Proportion of relapse-free patients at Month 3, 9 and 15 • Proportion of relapse-free patients with MRI activity-free (no new Gd+ T1 lesion or new/enlarged T2 lesion) at Month 3, 9 and 15 • Time to 3-month Confirmed Disability Worsening (3mCDW) • Time to 6-month Confirmed Disability Worsening (6mCDW) • Change in expanded disability status scale (EDSS) from baseline to end of study • Proportion of disability progression free patient at EoS • Number of Gadolinium enhancing (Gd+) T1 lesions of brain • Volume of Gd+ T1 lesions of brain • Number of new/enlarging T2 lesions of brain • Volume of new/enlarging T2 lesions of brain • Proportion of SAEs, and SAEs with hospitalizations between ofatumumab 20 mg s.c. and first line self-administered DMTs • Proportion of patients with adverse events, including injection related reactions • Proportion of patients who withdrew due to abnormal lab values • Proportion of treatment discontinuation or interruptions for safety/ tolerability reason • Compliance to treatment using patient diary ;Timepoint(s) of evaluation of this end point: At Months 3, 6, 9, 12 and 15. For full details, please refer to the assessment schedule in the protocol. | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed