An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab (ARTIOS)
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ClinicalTrials.gov Identifier: NCT04353492 |
Recruitment Status :
Recruiting
First Posted : April 20, 2020
Last Update Posted : April 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing Multiple Sclerosis | Biological: Ofatumumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 550 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 in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy |
Actual Study Start Date : | July 14, 2020 |
Estimated Primary Completion Date : | July 12, 2024 |
Estimated Study Completion Date : | January 6, 2025 |

Arm | Intervention/treatment |
---|---|
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
Patients in the ofatumumab will receive injections of ofatumumab provided in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
Other Name: OMB157 |
- Annual Relapse Rate (AAR) [ 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 safety

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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 multiple sclerosis (MS)
- Relapsing MS (RRMS or SPMS) course
- Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug
- Breakthrough disease as evidence by clinical relapses or MRI
- EDSS score of 0 to 4
Exclusion Criteria:
- Primary progressive MS or SPMS without disease activity
- Disease duration of more than 10 years since diagnosis
- Patients with an active chronic disease of the immune system other than MS
- Patients at risk of developing or having reactivation of hepatitis
- Patients with active systemic infections or with neurological findings consistent with PML Other protocol-defined inclusion/exclusion criteria may apply

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: | April 1, 2021 |
Last Verified: | March 2021 |
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 |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Ofatumumab Antineoplastic Agents |