Clinical trial NCT04353492: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: RMS
MS
multiple sclerosis
relapsing multiple sclerosis
OMB157
adult
secondary progressive MS
SPMS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Annual Relapse Rate (ARR)
timeFrame: Up to 96 weeks from baseline
Secondary outcomes:
measure: Safety evaluation
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Fullerton Neuro and Headache Ctr
state: California
city: Aurora
country: United States
facility: CU Anschutz Med Campus
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Hollywood
country: United States
facility: Memorial Hospital
state: Florida
city: Homestead
country: United States
facility: Homestead Assoc In Research Inc
state: Florida
city: Maitland
country: United States
facility: Neurology Associates PA
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Sarasota
country: United States
facility: Negroski Neurology
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Neuroscience Institute
state: Georgia
city: Suwanee
country: United States
facility: Georgia Neurology and Sleep Medicine Assoc
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Las Vegas
country: United States
facility: Cleveland Clinic Foundation
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Woodmere
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Westerville
country: United States
facility: Columbus Neuroscience
state: Ohio
city: Oklahoma City
country: United States
facility: Multiple Sclerosis Center of Excellence of OMRF
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Plano
country: United States
facility: North TX Inst of Neuro and Headache
state: Texas
city: Fairfax
country: United States
facility: INOVA Medical Group
state: Virginia
city: Milwaukee
country: United States
facility: Ascension St Francis Center
state: Wisconsin
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Tucuman
country: Argentina
facility: Novartis Investigative Site
city: New Lambton Heights
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Linz
country: Austria
facility: Novartis Investigative Site
state: Oberoesterreich
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Havirov
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Teplice
country: Czechia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Koeln
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Westerstede Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Larissa
country: Greece
facility: Novartis Investigative Site
state: GR
city: Greece
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Ciudad de Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Morelia
country: Mexico
facility: Novartis Investigative Site
state: Michoacan
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
state: Woj Kujawsko-pomorskie
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Kielce
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Braga
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Loures
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
state: SAU
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Karachi
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Maribor
country: Slovenia
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Sancaktepe
country: Turkey
facility: Novartis Investigative Site
state: Istanbul
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: TUR
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Samsun
country: Turkey
facility: Novartis Investigative Site
city: Trabzon
country: Turkey
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Swansea
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References: