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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
First received
Last updated
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
Health authority
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

Study Design


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
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