An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

• Register: ClinicalTrials.gov
• Last refreshed on: 19 May 2025
• Main ID: NCT04353492
• Date of registration: 16/04/2020
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab ARTIOS
• Scientific title: 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
• Date of first enrolment: July 14, 2020
• Target sample size: 562
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04353492
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Estonia, Germany, Greece, Hungary, Italy, Latvia, Lebanon, Mexico, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, United States

Key inclusion & exclusion 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)

- 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 or SPMS without disease activity

- Subjects meeting criteria for neuromyelitis optica

- 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


Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Biological: Ofatumumab

Primary Outcome(s)

Annual Relapse Rate (ARR) [Time Frame: Up to 96 weeks from baseline]

Secondary Outcome(s)

Safety evaluation [Time Frame: 96 weeks]

Secondary ID(s)

2019-001341-40

COMB157G23101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors