A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod.

Novartis Pharma AG33 sites in 8 countries293 target enrollmentStarted: July 8, 2024Last updated: July 24, 2024

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Novartis Pharma AG
Enrollment: 293
Locations: 33
Primary Endpoint: Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks

Study Overview Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type: Interventional

Eligibility Criteria

Ages: 18 years to 64 years (18-64 Years)
Accepts Healthy Volunteers: Yes

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

Exclusion Criteria

•Subjects with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014)
•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
•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

Outcomes

Primary Outcomes

Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks

Secondary Outcomes

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

Investigators

Sponsor

Novartis Pharma AG

Sponsor Class

Pharmaceutical company

Responsible Party

Principal Investigator

Novartis Pharma Arzneimittel GmbH

Scientific

Novartis Pharma AG

Study Sites (33)

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