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)

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Novartis

Status and phase

Active, not recruiting
Phase 3

Conditions

Relapsing Multiple Sclerosis

Treatments

Biological: Ofatumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04353492
COMB157G23101
2019-001341-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

564 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

564 participants in 1 patient group

Ofatumumab
Experimental group
Description:
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
Treatment:
Biological: Ofatumumab

Trial contacts and locations

123

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Data sourced from clinicaltrials.gov

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