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Relapsing Multiple SclerosisPhase 3ARTIOSNCT04353492

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

A Phase 3 study testing Ofatumumab in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 123 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Ofatumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
562 participants
Where
123 sitesin 27 countries
Study dates
14 Jul 2020to 11 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

123 sites in 27 countries.

123 sites in 27 countries

United States25 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Atlanta Neuroscience Institute

    Atlanta, Georgia, 30327

  • CU Anschutz Med Campus

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • INOVA Medical Group

    Fairfax, Virginia, 22030

  • Fullerton Neuro and Headache Ctr

    Fullerton, California, 92835

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Cleveland Clinic Foundation

    Las Vegas, Nevada, 89106

  • Neurology Associates PA

    Maitland, Florida, 32751

  • UM Department Of Neurology

    Miami, Florida, 33136

  • Ascension St Francis Center

    Milwaukee, Wisconsin, 53215

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107-5098

  • Saturn Research Solutions LLC

    Plano, Texas, 75024

  • Negroski Neurology

    Sarasota, Florida, 34233

  • Georgia Neurology and Sleep Medicine Assoc

    Suwanee, Georgia, 30024

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • University Of South Florida

    Tampa, Florida, 33612

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Columbus Neuroscience

    Westerville, Ohio, 43082

  • Five Towns Neuroscience Research

    Woodmere, New York, 11598

Other trials in United States

Germany12 sites

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50935

  • Novartis Investigative Site

    Cottbus, Brandenburg, 03048

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Munich, Bavaria, 81377

  • Novartis Investigative Site

    Osnabrück, Lower Saxony, 49076

  • Novartis Investigative Site

    Potsdam, 14471

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Westerstede Olden, 26655

Other trials in Germany

Spain8 sites

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Santa Cruz, Santa Cruz de Tenerife, 38009

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Valencia, 46010

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Slovakia7 sites

  • Novartis Investigative Site

    Banská Bystrica, Slovakia, 975 17

  • Novartis Investigative Site

    Bratislava, Slovakia, 813 69

  • Novartis Investigative Site

    Bratislava, Slovakia, 826 06

  • Novartis Investigative Site

    Bratislava, Slovakia, 833 05

  • Novartis Investigative Site

    Košice, Slovakia, 041 90

  • Novartis Investigative Site

    Nitra, Slovakia, 950 01

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02

Other trials in Slovakia

Bulgaria5 sites

  • Novartis Investigative Site

    Pleven, Bulgaria, 5800

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, Bulgaria, 1431

  • Novartis Investigative Site

    Sofia, 1113

  • Novartis Investigative Site

    Sofia, 1431

Other trials in Bulgaria

Czechia5 sites

  • Novartis Investigative Site

    Brno, 602 00

  • Novartis Investigative Site

    Havířov, 736 01

  • Novartis Investigative Site

    Hradec Králové, 500 05

  • Novartis Investigative Site

    Prague, 128 08

  • Novartis Investigative Site

    Teplice, 415 29

Other trials in Czechia

Poland5 sites

  • Novartis Investigative Site

    Bydgoszcz, Woj Kujawsko Pomorskie, 85-796

  • Novartis Investigative Site

    Katowice, 40-571

  • Novartis Investigative Site

    Kielce, 25 726

  • Novartis Investigative Site

    Lodz, 90-153

  • Novartis Investigative Site

    Wroclaw, 51-685

Other trials in Poland

Turkey (Türkiye)5 sites

  • Novartis Investigative Site

    Istanbul, Fatih, 34098

  • Novartis Investigative Site

    Istanbul, Sancaktepe, 34785

  • Novartis Investigative Site

    Izmir, 35100

  • Novartis Investigative Site

    Samsun, Atakum, 55200

  • Novartis Investigative Site

    Trabzon, Ortahisar, 61080

Other trials in Turkey (Türkiye)

Argentina4 sites

  • Novartis Investigative Site

    Buenos Aires, C1424BYD

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BZL

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSW

  • Novartis Investigative Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Austria4 sites

  • Novartis Investigative Site

    Linz, Upper Austria, A 4020

  • Novartis Investigative Site

    Linz, 4020

  • Novartis Investigative Site

    Vienna, State of Vienna, 1010

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Hungary4 sites

  • Novartis Investigative Site

    Budapest, HUN, 1135

  • Novartis Investigative Site

    Budapest, 1138

  • Novartis Investigative Site

    Budapest, 1204

  • Novartis Investigative Site

    Pécs, 7623

Other trials in Hungary

Italy4 sites

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Roma, RM, 00152

  • Novartis Investigative Site

    Verona, VR, 37134

Other trials in Italy

Portugal4 sites

  • Novartis Investigative Site

    Braga, 4710243

  • Novartis Investigative Site

    Lisbon, 1349-019

  • Novartis Investigative Site

    Loures, 2674-514

  • Novartis Investigative Site

    Porto, 4099-001

Other trials in Portugal

Australia3 sites

  • Novartis Investigative Site

    New Lambton Heights, New South Wales, 2305

  • Novartis Investigative Site

    Parkville, Victoria, 3050

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium3 sites

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Edegem, 2650

Other trials in Belgium

Greece3 sites

  • Novartis Investigative Site

    Larissa, 411 10

  • Novartis Investigative Site

    Thessaloniki, 53246

  • Novartis Investigative Site

    Thessaloniki, GR 54636

Other trials in Greece

Lebanon3 sites

  • Novartis Investigative Site

    Beirut, 113-0236

  • Novartis Investigative Site

    Beirut, 166830

  • Novartis Investigative Site

    Beirut, 8610

Other trials in Lebanon

Mexico3 sites

  • Novartis Investigative Site

    Mexico City, Mexico City, 03100

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700

  • Novartis Investigative Site

    Morelia, Michoacán, 58260

Other trials in Mexico

Russia3 sites

  • Novartis Investigative Site

    Moscow, 115516

  • Novartis Investigative Site

    Moscow, 127015

  • Novartis Investigative Site

    Saint Petersburg, 190000

Other trials in Russia

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 11315

  • Novartis Investigative Site

    Tartu, 50406

Other trials in Estonia

Latvia2 sites

  • Novartis Investigative Site

    Riga, LV, LV-1005

  • Novartis Investigative Site

    Riga, LV 1002

Other trials in Latvia

Saudi Arabia2 sites

  • Novartis Investigative Site

    Jeddah, 21499

  • Novartis Investigative Site

    Riyadh, SAU, 11525

Other trials in Saudi Arabia

Slovenia2 sites

  • Novartis Investigative Site

    Ljubljana, 1000

  • Novartis Investigative Site

    Maribor, Slovenia, 2000

Other trials in Slovenia

United Kingdom2 sites

  • Novartis Investigative Site

    Cardiff, CF14 4XW

  • Novartis Investigative Site

    Swansea, SA2 8QA

Other trials in United Kingdom

Canada1 site

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Norway1 site

  • Novartis Investigative Site

    Oslo, NO-0407

Other trials in Norway

Switzerland1 site

  • Novartis Investigative Site

    Basel, 4031

Other trials in Switzerland

About this study

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

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Read the detailed description

This was a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.

Being tested
Ofatumumab
Keywords
RMS, MS, multiple sclerosis, relapsing multiple sclerosis, OMB157, adult, secondary progressive MS, SPMS
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabBiological

    Also called OMB157

    Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)

Study groups in NCT04353492
Study groupRoleWhat they receive
OfatumumabExperimentalOfatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
Receives: Biological: Ofatumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Relapse Rate (ARR)

    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). Confirmed relapses are those accompanied by a clinically relevant change in the expanded disability status scale (EDSS).

    ARR was estimated from fitting a negative binomial regression model with log-link, and adjusted for prior MS therapies as a factor, number of relapses in previous year, baseline EDSS, baseline number of T1 Gd-enhancing lesions and the subject's age at baseline as covariates.

    The primary analysis describes the ARR with one-sided 95% confidence bound and test for null hypothesis (H0): ARR >=0.18 versus alternative hypothesis (H1): ARR<0.18.

    Measured: Up to 96 weeks from baseline

Secondary outcomes (1)

  1. Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of of participants with treatment emergent AEs and SAEs including injection related reactions, abnormal laboratory results or vital signs reported and qualifying as AEs.

    Measured: From treatment day 1 to 100 days after last treatment up to approximatelly 26.6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start14 Jul 2020
  3. Primary completion9 Oct 2024
  4. Study completion11 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
562 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353492
Sponsor's protocol ID
COMB157G23101
Other IDs
2019-001341-40, 2019
Acronym
ARTIOS
Status last verified
Mar 2026
First submitted
16 Apr 2020
Last updated
9 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Bove R, Langdon D, Maciejowski M, Jasinska E, Dufek M, Abeyewickreme A, Rauh A, Fu H, Khan IA, Bohringer M, Eichau SM, Derfuss T. Efficacy and safety of ofatumumab in participants with relapsing multiple sclerosis and breakthrough disease on oral fingolimod or fumarates: results from the ARTIOS study. J Neurol. 2026 Jun 29;273(7):434. doi: 10.1007/s00415-026-13960-5.

    PubMed 42371147

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ofatumumab in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 123 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Germany, Spain, Slovakia, Bulgaria and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Relapse Rate (ARR) (time frame: Up to 96 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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