Evidence map›Paper›PMID 41806309›Full record

ArticleNeurology and therapy2026

Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study.

Bruno Brochet, Dawn Langdon, Eva Kubala Havrdova, Jeanette Lechner-Scott, Xavier Montalban, Francesco Patti, Fredrik Piehl, Alessandra Solari, Raymond Hupperts, Nektaria Alexandri and 4 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Neurology and therapy, 2026. 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 NCT03369665 (A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad®), which is not on this 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.

NCT03369665 phase4completednot on this map

A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2018 to 2021Enrolled485ConditionsMultiple SclerosisArmsMavenclad®
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Bruno BrochetINSERM U1215, University of Bordeaux, Bordeaux, France. bruno.brochet@u-bordeaux.fr.ORCID http://orcid.org/0000-0003-3824-2796
Dawn LangdonDepartment of Psychology, Royal Holloway, University of London, Egham, Surrey, UK.ORCID http://orcid.org/0000-0003-1128-7417
Eva Kubala HavrdovaFirst Medical Faculty, Department of Neurology and Center for Clinical Neuroscience, Charles University, Prague, Czech Republic.ORCID http://orcid.org/0000-0002-9543-4359
Jeanette Lechner-ScottUniversity of Newcastle, Newcastle, NSW, Australia.ORCID http://orcid.org/0000-0002-3850-447X
Xavier MontalbanDepartment of Neurology-Neuroimmunology Centre of Multiple Sclerosis of Catalonia (Cemcat), University Hospital Vall d'Hebron, Barcelona, Spain.ORCID http://orcid.org/0000-0002-0098-9918
Francesco PattiDepartment of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, University of Catania, and Azienda Ospedaliero Universitaria Policlinico "G Rodolico"- San Marco, University of Catania, Catania, Italy.ORCID http://orcid.org/0000-0002-6923-0846
Fredrik PiehlDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.ORCID http://orcid.org/0000-0001-8329-5219
Alessandra SolariUnit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.ORCID http://orcid.org/0000-0001-9930-7579
Raymond HuppertsZuyderland Medisch Centrum Sittard, Maastricht University Medical Center, Maastricht, The Netherlands.ORCID http://orcid.org/0000-0003-2106-2158
Nektaria AlexandriMerck Healthcare KGaA, Darmstadt, Germany.ORCID http://orcid.org/0000-0002-9806-8358
Annette LehnMerck Healthcare KGaA, Darmstadt, Germany.ORCID http://orcid.org/0000-0002-1083-9796
Andrzej SmykMerck Healthcare KGaA, Darmstadt, Germany.ORCID http://orcid.org/0000-0002-7794-112X
Krzysztof SelmajCenter for Neurology, Lodz, Poland.ORCID http://orcid.org/0000-0003-1213-7218
CLARIFY-MS Investigators

Funding

Merck Healthcare KGaA Crossref Funder ID: 10.13039/100009945
6 · The paper itself

Abstract

introductionCognitive impairment can affect people with multiple sclerosis (MS) at all stages, negatively impacting their work performance and quality of life. This study aimed to report the cognitive function and employment status data for participants with highly active relapsing MS (RMS) treated with cladribine tablets (CladT) during the 2-year, prospective, open-label, exploratory, single-arm, multicentre, phase IV CLARIFY-MS study.

methodsIn this post hoc analysis, changes in cognitive function at month (M)12 and M24 (vs baseline) were measured using the Brief International Cognitive Assessment for MS (BICAMS) battery. Additional analyses were conducted to assess clinically meaningful 4- and 8-point changes in Symbol Digit Modalities Test (SDMT) scores. The employment status of participants was determined through a survey at baseline and M24.

resultsBICAMS parameter scores remained stable over 2 years in CladT-treated participants. As determined by a 4- and 8-point change, a high proportion of participants had increased or stable SDMT scores at M24 versus baseline. The mean annualised percentage brain volume change (PBVC) in participants was low. No correlation was found between changes in BICAMS parameter scores and annualised PBVC. Furthermore, no major differences in the employment status of participants were observed over 2 years, with > 40% of participants being in full-time employment during the study.

conclusionsMost CLARIFY-MS participants had increased or stable information processing speed at M24 (vs baseline), as determined using clinically meaningful 4- and 8-point changes in SDMT scores. Overall, the cognitive function and employment status of CladT-treated participants with highly active RMS remained stable over 2 years. TRIAL REGISTRY DETAILS: URL: https://clinicaltrials.gov/ct2/show/NCT03369665 ; ClinicalTrials.gov Identifier: NCT03369665.

Indexed as

BICAMSCladribine tabletsCLARIFY-MSCognitionEmploymentMSMultiple SclerosisRelapsing MSSDMTWork

Identifiers

PMID41806309
PMCPMC13396085

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.