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

CompletadoFase 3ClinicalTrials.gov

ID: NCT04353492Tipo: INTERVENTIONALInicio: 14 de jul de 2020Fin estimado: 11 de mar de 2025

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 60 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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)

Ubicaciones

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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