Evidence map›Paper›PMID 40775552›Full record

Trial reportNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2025

A multicentre, prospective, randomized, open-label pragmatic trial to compare the effectiveness and safety of interferon beta-1a and glatiramer-acetate in paediatric patients affected by Multiple Sclerosis.

Marta Simone, Roberto Palumbi, Mariaclara Achille, Stefania Micella, Mara Pascali, Antonia Peschechera, Alessandra Gabellone, Lucia Marzulli, Andrea De Giacomo, Giulia Maggi and 9 more

Abstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

19 authors.

Marta SimoneChild Neuropsychiatry Unit, Department of Precision and Regenerative Medicine and Jonic Area (Dimepre-J), University of Bari "Aldo Moro, Bari, Italy. simonemarta378@gmail.com.ORCID http://orcid.org/0000-0003-4381-4613
Roberto PalumbiChild Neuropsychiatry Unit, Department of Translational Biomedicines and Neurosciences (DiBrain), University of Bari "Aldo Moro, Bari, Italy.
Mariaclara AchilleChild Neuropsychiatry Unit, Department of Translational Biomedicines and Neurosciences (DiBrain), University of Bari "Aldo Moro, Bari, Italy.
Stefania MicellaChild Neuropsychiatry Unit, Department of Translational Biomedicines and Neurosciences (DiBrain), University of Bari "Aldo Moro, Bari, Italy.
Mara PascaliChild Neuropsychiatry Unit, Department of Translational Biomedicines and Neurosciences (DiBrain), University of Bari "Aldo Moro, Bari, Italy.
Antonia PeschecheraChild Neuropsychiatry Unit, Department of Precision and Regenerative Medicine and Jonic Area (Dimepre-J), University of Bari "Aldo Moro, Bari, Italy.
Alessandra GabelloneChild Neuropsychiatry Unit, Department of Precision and Regenerative Medicine and Jonic Area (Dimepre-J), University of Bari "Aldo Moro, Bari, Italy.
Lucia MarzulliChild Neuropsychiatry Unit, Department of Precision and Regenerative Medicine and Jonic Area (Dimepre-J), University of Bari "Aldo Moro, Bari, Italy.
Andrea De GiacomoChild Neuropsychiatry Unit, Department of Translational Biomedicines and Neurosciences (DiBrain), University of Bari "Aldo Moro, Bari, Italy.
Giulia MaggiConsorzio Per Valutazioni Biologiche e Farmacologiche (CVBF), Bari, Italy.
Giorgio ReggiardoConsorzio Per Valutazioni Biologiche e Farmacologiche (CVBF), Bari, Italy.
Mariagrazia FelisiConsorzio Per Valutazioni Biologiche e Farmacologiche (CVBF), Bari, Italy.
Rosa PadulaConsorzio Per Valutazioni Biologiche e Farmacologiche (CVBF), Bari, Italy.
Donato BonifaziConsorzio Per Valutazioni Biologiche e Farmacologiche (CVBF), Bari, Italy.
Massimiliano ValerianiDevelopmental Neurology Unit, Bambino Gesù Children's Hospital, IRCCS, 00165, Rome, Italy.
Laura PapettiDevelopmental Neurology Unit, Bambino Gesù Children's Hospital, IRCCS, 00165, Rome, Italy.
Roberta LanzilloDepartment of Neurosciences and Reproductive and Odontostomatological Sciences, University of Naples Federico II, Naples, Italy.
Valentina Torri ClericiFoundation Neurological Institute C. Besta, Milan, Italy.
Lucia MargariChild Neuropsychiatry Unit, Department of Precision and Regenerative Medicine and Jonic Area (Dimepre-J), University of Bari "Aldo Moro, Bari, Italy.

Funding

Agenzia Italiana del Farmaco, Ministero della Salute AIFA-2016-02365052
6 · The paper itself

Abstract

backgroundPaediatric-onset Multiple Sclerosis (POMS) is a rare, highly active disease requiring timely disease-modifying therapy.

objectivesThis trial compared the efficacy and safety of intramuscular (i.m.) Interferon beta-1a (IFN-beta 1a) and subcutaneous (s.c.) Glatiramer Acetate (GA).

methodsA 96-week, Phase IIIb, multicenter, open-label randomized trial enrolled 30 participants (ages 12-17). Patients were randomized into two groups: 15 received i.m. IFN-beta 1a, and 15 received s.c. GA. The primary endpoint was MRI disease activity-free status; secondary outcomes included annualized relapse rate (ARR), time to first relapse, Expanded Disability Status Scale (EDSS), cognitive and fatigue scores, and quality of life.

resultsThe groups differed by age but not sex. MRI disease activity-free status did not differ (p = 0.09). ARR was significantly lower in the GA group (0.20; 95% CI 0.08-0.42) than in the IFN-beta 1a group (0.57; 95% CI 0.31-0.95, p = 0.02). EDSS, cognitive, fatigue, and quality-of-life scores were comparable. Notably, 50% of GA patients and 30% of IFN-beta 1a patients switched to higher efficacy treatments.

conclusionsBoth treatments showed similar efficacy and safety, but early high-efficacy therapy may be preferable for POMS management.

trial registrationEudraCT Number: 2017-005129-18. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-005129-18/IT.

Indexed as

Glatiramer AcetateImmunologic FactorsInterferon beta-1aMultiple SclerosisAdolescentChildFemaleHumansInjections, IntramuscularInjections, SubcutaneousMaleProspective StudiesQuality of LifeTreatment OutcomeGlatiramer AcetateImmunologic FactorsInterferon beta-1aGlatiramer acetateInterferon beta-1aPhase III randomized clinical trialPOMSPragmatic study

Identifiers

PMID40775552
PMCPMC12488838

What Socratic holds

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Registered trials

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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.