Trial reportNeurology2018
Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.
Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04466150 (Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset), which is not on this map. Cited by 117 papers, 4 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 4 pooled it
–field-weighted citation impact
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
NCT04466150 phase4active not recruitingnot on this mapstarted 2020, after this paper: background citation
Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset
Who cites it
117 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- The Efficacy and Safety of Anti-CD20 Antibody Treatments in Relapsing Multiple Sclerosis: A Systematic Review and Network Meta-analysis.CNS drugs · 2022Pooled it
- Systematic Review of Safety and Efficacy of Second- and Third-Generation CD20-Targeting Biologics in Treating Immune-Mediated Disorders.Frontiers in immunology · 2021Pooled it
- Pharmacokinetics, Pharmacodynamics, Bioavailability, and Immunogenicity of Obexelimab Following Subcutaneous Administration in Healthy Japanese and Non-Japanese Volunteers.Advances in therapy · 2025Trial
- Efficacy and safety results after >3.5 years of treatment with the Bruton's tyrosine kinase inhibitor evobrutinib in relapsing multiple sclerosis: Long-term follow-up of a Phase II randomised clinical trial with a cerebrospinal fluid sub-study.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024Trial
- Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis.Journal of neurology, neurosurgery, and psychiatry · 2023Trial
- Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II.Multiple sclerosis (Houndmills, Basingstoke, England) · 2022Trial
- Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years.Multiple sclerosis (Houndmills, Basingstoke, England) · 2022Trial
- Ocrelizumab in relapsing and primary progressive multiple sclerosis: Pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO.British journal of clinical pharmacology · 2021Trial
- A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2021Trial
- Safety and efficacy of anti-CD20 monoclonal antibodies versus teriflunomide in relapsing multiple sclerosis: a systematic review and meta-analysis.Acta neurologica Belgica · 2026Article
- Real-World Effectiveness and Safety of Ofatumumab: Analysis of B Cell Depletion, Comorbidities and Ethnicity in a Spanish Cohort.Neurology and therapy · 2026Article
- Ofatumumab therapy modulates the meningeal lymphatic draining function in patients with multiple sclerosis: a pilot study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- Article
- Real World Data of Laboratory Changes and Immunophenotyping in Patients with Multiple Sclerosis Treated with Ofatumumab-Single Center Experience.Biomedicines · 2026Article
- The real-world effectiveness and safety of off-label rituximab in a large cohort of Middle Eastern multiple sclerosis patients.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Observational
- Comparative Effectiveness of Rituximab Dosed Every 6 and 12 Months in Relapsing Multiple Sclerosis.Neurology · 2026Article
- Sequential efgartigimod and ofatumumab for stiff-person syndrome: a case report illustrating a pathophysiology-informed strategy and literature review.Frontiers in immunology · 2026Review
- [Ofatumumab in the treatment of multiple sclerosis - A summary of preclinical and clinical data].Fortschritte der Neurologie-Psychiatrie · 2026Review
57 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
11 authors.
Amit Bar-OrFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA. amitbar@upenn.edu.
Richard A GroveFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Daren J AustinFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Jerry M TolsonFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Susan A VanMeterFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Eric W LewisFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Frederick J DerosierFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Monica C LopezFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Sarah T KavanaghFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Aaron E MillerFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Per S SorensenFrom the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Neuroimmunology Unit (A.B.-O.), Montreal Neurological Institute and Hospital, McGill University and McGill University Health Center, Quebec, Canada; Neurosciences Clinical Statistics (R.A.G.), Clinical Pharmacology (R.A.G., D.J.A.), and Modeling and Simulation (D.J.A.), GlaxoSmithKline, Uxbridge, Middlesex, UK; Neurosciences Therapy Area Unit (J.M.T., S.A.V., E.W.L., F.J.D., M.C.L., S.T.K.), SAVM (F.J.D., M.C.L.), Global Clinical Safety and Pharmacovigilance (E.W.L.), and Neurosciences Clinical Statistics (SecTK), GlaxoSmithKline, Research Triangle Park, NC; Department of Neurology (A.E.M.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY; and Danish Multiple Sclerosis Center (P.S.S.), Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Dr. Derosier is now at Clinical Development, Isis Pharmaceutical, Carlsbad, CA.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess dose-response effects of the anti-CD20 monoclonal antibody ofatumumab on efficacy and safety outcomes in a phase 2b double-blind study of relapsing forms of multiple sclerosis (RMS).
methodsPatients (n = 232) were randomized to ofatumumab 3, 30, or 60 mg every 12 weeks, ofatumumab 60 mg every 4 weeks, or placebo for a 24-week treatment period, with a primary endpoint of cumulative number of new gadolinium-enhancing lesions (per brain MRI) at week 12. Relapses and safety/tolerability were assessed, and CD19+ peripheral blood B-lymphocyte counts measured. Safety monitoring continued weeks 24 to 48 with subsequent individualized follow-up evaluating B-cell repletion.
resultsThe cumulative number of new lesions was reduced by 65% for all ofatumumab dose groups vs placebo (
conclusionImaging showed that all subcutaneous ofatumumab doses demonstrated efficacy (most robust: cumulative doses ≥30 mg/12 wk), with a safety profile consistent with existing ofatumumab data. This treatment effect also occurred with dosage regimens that only partially depleted circulating B cells. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with RMS, ofatumumab decreases the number of new MRI gadolinium-enhancing lesions 12 weeks after treatment initiation.
Indexed as
Injections, SubcutaneousAcetaminophenAdministration, OralAdultAnalgesics, Non-NarcoticAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDisability EvaluationDouble-Blind MethodFemaleFollow-Up StudiesHistamine AntagonistsHumansImage Processing, Computer-AssistedMagnetic Resonance ImagingAcetaminophenAnalgesics, Non-NarcoticAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsHistamine Antagonistsofatumumab
Identifiers
What Socratic holds
Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390
Registered trials
NCT04466150ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.