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)

March 27, 2026 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

562

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1424BYD
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentina, 4000
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000BZL
        • Novartis Investigative Site
      • Rosario, Santa Fe Province, Argentina, S2000DSW
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Novartis Investigative Site
  • Austria
      • Linz, Austria, 4020
        • Novartis Investigative Site
      • Vienna, Austria, 1090
        • Novartis Investigative Site
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1010
        • Novartis Investigative Site
    • Upper Austria
      • Linz, Upper Austria, Austria, A 4020
        • Novartis Investigative Site
  • Belgium
      • Bruges, Belgium, 8000
        • Novartis Investigative Site
      • Brussels, Belgium, 1200
        • Novartis Investigative Site
      • Edegem, Belgium, 2650
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1113
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
    • Bulgaria
      • Pleven, Bulgaria, Bulgaria, 5800
        • Novartis Investigative Site
      • Sofia, Bulgaria, Bulgaria, 1431
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 602 00
        • Novartis Investigative Site
      • Havířov, Czechia, 736 01
        • Novartis Investigative Site
      • Hradec Králové, Czechia, 500 05
        • Novartis Investigative Site
      • Prague, Czechia, 128 08
        • Novartis Investigative Site
      • Teplice, Czechia, 415 29
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 11315
        • Novartis Investigative Site
      • Tartu, Estonia, 50406
        • Novartis Investigative Site
  • Germany
      • Bielefeld, Germany, 33647
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Leipzig, Germany, 04275
        • Novartis Investigative Site
      • Potsdam, Germany, 14471
        • Novartis Investigative Site
      • Siegen, Germany, 57076
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Novartis Investigative Site
      • Ulm, Germany, 89073
        • Novartis Investigative Site
      • Westerstede Olden, Germany, 26655
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Novartis Investigative Site
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • Novartis Investigative Site
    • Lower Saxony
      • Osnabrück, Lower Saxony, Germany, 49076
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50935
        • Novartis Investigative Site
  • Greece
      • Larissa, Greece, 411 10
        • Novartis Investigative Site
      • Thessaloniki, Greece, GR 54636
        • Novartis Investigative Site
      • Thessaloniki, Greece, 53246
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1138
        • Novartis Investigative Site
      • Budapest, Hungary, 1204
        • Novartis Investigative Site
      • Pécs, Hungary, 7623
        • Novartis Investigative Site
    • HUN
      • Budapest, HUN, Hungary, 1135
        • Novartis Investigative Site
  • Italy
    • FI
      • Florence, FI, Italy, 50134
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00152
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37134
        • Novartis Investigative Site
  • Latvia
      • Riga, Latvia, LV 1002
        • Novartis Investigative Site
    • LV
      • Riga, LV, Latvia, LV-1005
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon, 166830
        • Novartis Investigative Site
      • Beirut, Lebanon, 8610
        • Novartis Investigative Site
      • Beirut, Lebanon, 113-0236
        • Novartis Investigative Site
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Novartis Investigative Site
      • Mexico City, Mexico City, Mexico, 03100
        • Novartis Investigative Site
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, NO-0407
        • Novartis Investigative Site
  • Poland
      • Katowice, Poland, 40-571
        • Novartis Investigative Site
      • Kielce, Poland, 25 726
        • Novartis Investigative Site
      • Lodz, Poland, 90-153
        • Novartis Investigative Site
      • Wroclaw, Poland, 51-685
        • Novartis Investigative Site
    • Woj Kujawsko Pomorskie
      • Bydgoszcz, Woj Kujawsko Pomorskie, Poland, 85-796
        • Novartis Investigative Site
  • Portugal
      • Braga, Portugal, 4710243
        • Novartis Investigative Site
      • Lisbon, Portugal, 1349-019
        • Novartis Investigative Site
      • Loures, Portugal, 2674-514
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Novartis Investigative Site
  • Russia
      • Moscow, Russia, 127015
        • Novartis Investigative Site
      • Moscow, Russia, 115516
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 190000
        • Novartis Investigative Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21499
        • Novartis Investigative Site
    • SAU
      • Riyadh, SAU, Saudi Arabia, 11525
        • Novartis Investigative Site
  • Slovakia
    • Slovakia
      • Banská Bystrica, Slovakia, Slovakia, 975 17
        • Novartis Investigative Site
      • Bratislava, Slovakia, Slovakia, 813 69
        • Novartis Investigative Site
      • Bratislava, Slovakia, Slovakia, 826 06
        • Novartis Investigative Site
      • Bratislava, Slovakia, Slovakia, 833 05
        • Novartis Investigative Site
      • Košice, Slovakia, Slovakia, 041 90
        • Novartis Investigative Site
      • Nitra, Slovakia, Slovakia, 950 01
        • Novartis Investigative Site
      • Trnava, Slovakia, Slovakia, 917 02
        • Novartis Investigative Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Novartis Investigative Site
    • Slovenia
      • Maribor, Slovenia, Slovenia, 2000
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Novartis Investigative Site
      • Valencia, Spain, 46010
        • Novartis Investigative Site
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Novartis Investigative Site
    • Santa Cruz de Tenerife
      • Santa Cruz, Santa Cruz de Tenerife, Spain, 38009
        • Novartis Investigative Site
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35100
        • Novartis Investigative Site
    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55200
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34098
        • Novartis Investigative Site
    • Ortahisar
      • Trabzon, Ortahisar, Turkey (Türkiye), 61080
        • Novartis Investigative Site
    • Sancaktepe
      • Istanbul, Sancaktepe, Turkey (Türkiye), 34785
        • Novartis Investigative Site
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Novartis Investigative Site
      • Swansea, United Kingdom, SA2 8QA
        • Novartis Investigative Site
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Fullerton Neuro and Headache Ctr
    • Colorado
      • Aurora, Colorado, United States, 80045
        • CU Anschutz Med Campus
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Services
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System
      • Homestead, Florida, United States, 33033
        • Homestead Assoc In Research Inc
      • Maitland, Florida, United States, 32751
        • Neurology Associates PA
      • Miami, Florida, United States, 33136
        • UM Department Of Neurology
      • Sarasota, Florida, United States, 34233
        • Negroski Neurology
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Atlanta NeuroScience Institute
      • Suwanee, Georgia, United States, 30024
        • Georgia Neurology and Sleep Medicine Assoc
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic Foundation
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico
    • New York
      • Woodmere, New York, United States, 11598
        • Five Towns Neuroscience Research
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Westerville, Ohio, United States, 43082
        • Columbus Neuroscience
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Multiple Sclerosis Center of Excellence of OMRF
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5098
        • Thomas Jefferson University Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Plano, Texas, United States, 75024
        • Saturn Research Solutions LLC
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Inova Medical Group
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Ascension St Francis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ofatumumab
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
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 Names:
  • OMB157

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized 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). 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.
Up to 96 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From treatment day 1 to 100 days after last treatment up to approximatelly 26.6 months
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.
From treatment day 1 to 100 days after last treatment up to approximatelly 26.6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Actual)

October 9, 2024

Study Completion (Actual)

March 11, 2025

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMB157G23101
  • 2019-001341-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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