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

Relapsing Multiple Sclerosis Clinical Trial

— ARTIOS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04353492
• Other study ID #: COMB157G23101
• Secondary ID: 2019-001341-40
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 14, 2020
• Est. completion date: April 11, 2025

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

This is 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 564
• Est. completion date: April 11, 2025
• Est. primary completion date: April 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

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)

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Tucuman
Australia	Novartis Investigative Site	New Lambton Heights	New South Wales
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	Woolloongabba	Queensland
Austria	Novartis Investigative Site	Linz	Oberoesterreich
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Edegem	Antwerpen
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Toronto	Ontario
Czechia	Novartis Investigative Site	Brno	Czech Republic
Czechia	Novartis Investigative Site	Havirov	Czech Republic
Czechia	Novartis Investigative Site	Hradec Kralove	CZE
Czechia	Novartis Investigative Site	Praha
Czechia	Novartis Investigative Site	Teplice	Czech Republic
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Cottbus
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Koln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Westerstede Oldenburg
Greece	Novartis Investigative Site	Greece
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Budapest	HUN
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Pecs
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Verona	VR
Latvia	Novartis Investigative Site	Riga	LV
Latvia	Novartis Investigative Site	Riga
Lebanon	Novartis Investigative Site	Ashrafieh
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Mexico	Novartis Investigative Site	Ciudad de Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Morelia	Michoacan
Norway	Novartis Investigative Site	Oslo
Poland	Novartis Investigative Site	Bydgoszcz	Woj Kujawsko-pomorskie
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Kielce
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Braga
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Loures
Portugal	Novartis Investigative Site	Porto
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St Petersburg
Saudi Arabia	Novartis Investigative Site	Jeddah
Saudi Arabia	Novartis Investigative Site	Riyadh	SAU
Slovakia	Novartis Investigative Site	Banska Bystrica
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Trnava
Slovenia	Novartis Investigative Site	Ljubljana
Slovenia	Novartis Investigative Site	Maribor
Spain	Novartis Investigative Site	Baracaldo	Vizcaya
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	El Palmar	Murcia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Santa Cruz de Tenerife
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Switzerland	Novartis Investigative Site	Basel
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Samsun
Turkey	Novartis Investigative Site	Sancaktepe	Istanbul
Turkey	Novartis Investigative Site	Trabzon
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Swansea
United States	University of New Mexico	Albuquerque	New Mexico
United States	Atlanta Neuroscience Institute	Atlanta	Georgia
United States	CU Anschutz Med Campus	Aurora	Colorado
United States	Johns Hopkins MS Center	Baltimore	Maryland
United States	Cleveland Clinic Foundation .	Cleveland	Ohio
United States	INOVA Medical Group .	Fairfax	Virginia
United States	Fullerton Neuro and Headache Ctr	Fullerton	California
United States	Memorial Hospital	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Cleveland Clinic Foundation	Las Vegas	Nevada
United States	Neurology Associates, PA	Maitland	Florida
United States	Homestead Associates in Research Inc	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Ascension St Francis Center	Milwaukee	Wisconsin
United States	Christiana Care Health Services	Newark	Delaware
United States	Multiple Sclerosis Center of Excellence of OMRF	Oklahoma City	Oklahoma
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	North TX Inst of Neuro and Headache	Plano	Texas
United States	Negroski Neurology	Sarasota	Florida
United States	Georgia Neurology and Sleep Medicine Assoc	Suwanee	Georgia
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	University of South Florida .	Tampa	Florida
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Novartis Investigative Site	Westerville	Ohio
United States	Novartis Investigative Site	Woodmere	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual 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	Up to 96 weeks from baseline
Secondary	Safety evaluation	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	96 weeks