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: • Diagnosis of MS according to the 2017 Revised McDonald criteria • Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS) (Lublin et al 2014) • Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive) • MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT • Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration • Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions) • Neurologically stable within one 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 555 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014) • Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al 2015) • Disease duration of more than 10 years since diagnosis • Pregnant or nursing(lactating) women • Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication • Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome • Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS) • Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML • Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice • Subjects with active hepatitis B and C disease, assessed locally • Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration • Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.) • Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator Please see protocol for complete detailed list of exclusion criteria.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects with adverse events, including injection related reactions • Proportion of patients with laboratory or vital signs results meeting abnormal criteria • The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons;Timepoint(s) of evaluation of this end point: 96 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the effectiveness of ofatumumab 20 mg s.c. administered every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on fumarates or fingolimod;Secondary Objective: Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on fumarates or fingolimod;Primary end point(s): Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks;Timepoint(s) of evaluation of this end point: 96 weeks | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lebanon, Mexico, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactInformacní služba – klin. hodnocení
Novartis s.r.o.
Outcome results
None listed