Evidence map›Paper›PMID 40462564›Full record

Trial reportEuropean journal of neurology2025

Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials.

Sarah Harris, Giancarlo Comi, Bruce A C Cree, Douglas L Arnold, Lawrence Steinman, James K Sheffield, Rachel Maddux, Harry Southworth, Ludwig Kappos, Jeffrey A Cohen

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT02047734 phase3completednot on this map

A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

TypeinterventionalSponsorCelgeneRan2013 to 2017Enrolled1,320ConditionsRelapsing Multiple SclerosisArmsOzanimod, Ozanimod placebo, Interferon beta-1a, Interferon beta-1a placebo
NCT02294058 phase3completednot on this map

A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

TypeinterventionalSponsorCelgeneRan2014 to 2016Enrolled1,346ConditionsMultiple SclerosisArmsOzanimod, Interferon beta-1a, Placebo to ozanimod, Placebo to interferon beta-1a
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Astrocytes in Multiple Sclerosis: Getting to the Core.International journal of molecular sciences · 2026
    Review
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Sarah HarrisBristol Myers Squibb, Princeton, New Jersey, USA.ORCID 0000-0001-9433-7496
Giancarlo ComiVita-Salute San Raffaele University and Casa di Cura Igea, Milan, Italy.
Bruce A C CreeWeill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.
Douglas L ArnoldNeuroRx Research and Montréal Neurological Institute, McGill University, Quebec, Canada.
Lawrence SteinmanDepartment of Neurology and Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, California, USA.
James K SheffieldBristol Myers Squibb, Princeton, New Jersey, USA.
Rachel MadduxBristol Myers Squibb, Princeton, New Jersey, USA.
Harry SouthworthData Clarity Consulting Ltd, Stockport, UK.
Ludwig KapposResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Head Organs, Spine and Neuromedicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland.
Jeffrey A CohenMellen Center for MS Treatment and Research, Department of Neurology, Cleveland Clinic, Cleveland, Ohio, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis post hoc analysis investigated relationships between baseline plasma glial fibrillary acidic protein (GFAP), a potential biomarker for multiple sclerosis (MS), and baseline characteristics and on-treatment outcomes in participants with relapsing MS (RMS) from two Phase 3 trials that randomly assigned ozanimod 0.46 mg or 0.92 mg or interferon β-1a 30 μg.

methodsIn the Phase 3 trials (SUNBEAM [ClinicalTrials.gov: NCT02294058; EudraCT: 2014-002320-27], duration: ≥ 12 months; and RADIANCE [ClinicalTrials.gov: NCT02047734; EudraCT: 2012-002714-40], duration: 24 months) baseline plasma GFAP was measured via Simoa (Quanterix). Adjusted regression models were used to determine relationships between baseline GFAP and baseline participant characteristics and to predict on-treatment outcomes.

resultsBaseline GFAP was associated with sex and had inverse associations with baseline body mass index and whole brain volume (WBV). Baseline GFAP had positive associations with baseline age, neurofilament light chain, numbers of gadolinium-enhancing (GdE) and T2 lesions, and Expanded Disability Status Scale (EDSS) score. Baseline GFAP had inverse associations with on-treatment WBV and the proportion of participants with no evidence of disease activity-3. Baseline GFAP had positive associations with on-treatment number of relapses through Months 12 and 24, number of GdE lesions at Month 12, number of new/enlarging T2 lesions over 12 months, and Month 12 EDSS score. In a multivariable lasso model, baseline GFAP concentration independently predicted only the number of relapses through Month 12.

conclusionsThese data suggest that plasma GFAP is a relapse-independent metric of baseline disease severity and a predictor of treatment response in participants with RMS.

Indexed as

Glial Fibrillary Acidic ProteinMultiple Sclerosis, Relapsing-RemittingOxadiazolesOximesSphingosine 1 Phosphate Receptor ModulatorsAdultBiomarkersFemaleHumansIndansInterferon beta-1aMaleMiddle AgedTreatment OutcomeBiomarkersGFAP protein, humanGlial Fibrillary Acidic ProteinIndansInterferon beta-1aOxadiazolesOximesozanimodSphingosine 1 Phosphate Receptor Modulatorsastrocytesglial fibrillary acidic proteinintermediate filamentsmultiple sclerosisozanimod

Identifiers

PMID40462564
PMCPMC12134391

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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 OpenQuestion graph.