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)
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ClinicalTrials.gov Identifier: NCT04353492 |
Recruitment Status :
Recruiting
First Posted : April 20, 2020
Last Update Posted : August 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing Multiple Sclerosis | Biological: Ofatumumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 555 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | July 14, 2020 |
Estimated Primary Completion Date : | October 31, 2024 |
Estimated Study Completion Date : | May 1, 2025 |

Arm | Intervention/treatment |
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Experimental: Ofatumumab
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
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Biological: Ofatumumab
Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
Other Name: OMB157 |
- Annual Relapse Rate (ARR) [ Time Frame: Up to 96 weeks from baseline ]ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
- Safety evaluation [ Time Frame: 96 weeks ]Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs, as well as proportion of patients discontinuing treatment due to insufficient effectiveness or tolerability/safety reasons

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353492
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |

Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04353492 |
Other Study ID Numbers: |
COMB157G23101 2019-001341-40 ( EudraCT Number ) |
First Posted: | April 20, 2020 Key Record Dates |
Last Update Posted: | August 10, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
RMS MS multiple sclerosis relapsing multiple sclerosis |
OMB157 adult secondary progressive MS SPMS |
Multiple Sclerosis Sclerosis Ofatumumab Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Antineoplastic Agents |