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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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ClinicalTrials.gov Identifier: NCT04353492
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Biological: Ofatumumab Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 555 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : July 12, 2024
Estimated Study Completion Date : January 6, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ofatumumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ofatumumab
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
 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)
Other Name: OMB157


Outcome Measures
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Primary Outcome Measures :
  1. Annual Relapse Rate (ARR) [ Time Frame: Up to 96 weeks from baseline ]
    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


Secondary Outcome Measures :
  1. Safety evaluation [ Time Frame: 96 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353492


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04353492    
Other Study ID Numbers: COMB157G23101
2019-001341-40 ( EudraCT Number )
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
RMS
MS
multiple sclerosis
relapsing multiple sclerosis
 OMB157
adult
secondary progressive MS
SPMS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ofatumumab
Antineoplastic Agents