Evidence map›Paper›PMID 23263473›Full record

Trial reportJournal of neurology2013

MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study.

Giancarlo Comi, Stuart D Cook, Gavin Giovannoni, Kottil Rammohan, Peter Rieckmann, Per Soelberg Sørensen, Patrick Vermersch, Anthony C Hamlett, Vissia Viglietta, Steven J Greenberg

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

Trial report in Journal of neurology, 2013. 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 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 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.

NCT04178005 phase4active not recruitingnot on this mapstarted 2020, after this paper: background citation

Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2020 to 2026Enrolled40ConditionsMultiple SclerosisArmsCladribine
NCT04550455 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

A Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis (SPMS)Subjects Treated With Cladribine Tablets

TypeinterventionalSponsorKeith Edwards, M.D.Ran2020 to 2025Enrolled30ConditionsMultiple SclerosisArmsCladribine Tablets
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  18. Escalation vs. Early Intense Therapy in Multiple Sclerosis.Journal of personalized medicine · 2022
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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.

Giancarlo ComiDepartment of Neurology and Institute of Experimental Neurology, Scientific Institute H.S. Raffaele, Università Vita-Salute San Raffaele, via Olgettina 60, 20132 Milan, Italy. comi.giancarlo@hsr.it
Stuart D Cook
Gavin Giovannoni
Kottil Rammohan
Peter Rieckmann
Per Soelberg Sørensen
Patrick Vermersch
Anthony C Hamlett
Vissia Viglietta
Steven J Greenberg

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing-remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions/patient/scan. MRI-measured disease activity was significantly reduced in both cladribine tablets groups versus placebo. The proportion of patients with no active lesions at study end was: T1 Gd+ lesions: 86.8 and 91.0 versus 48.3 % (p < 0.001); active T2 lesions: 61.7 and 62.5 versus 28.4 % (p < 0.001); CU lesions: 59.6 and 60.7 versus 26.1 % (p < 0.001). Clinically meaningful and significant reductions in active lesion counts and increases in proportions of active lesion-free patients were achieved consistently in cladribine tablet groups when data were stratified by baseline disease characteristics. For example, the percentage of patients who remained lesion-free over the study was significantly greater in cladribine tablet groups than in the placebo group for all lesion types regardless of relapse category at baseline (p < 0.001 for all analyses of patients with ≤1 or 2 relapses; p ≤ 0.022 for analyses of patients with ≥3 relapses). MRI-measured disease activity was greatly reduced by both doses of cladribine tablets, with consistent effect across clinically relevant patient populations. These findings add to our scientific understanding of the neurological impact of this therapeutic modality in patients with RRMS.

Indexed as

Treatment OutcomeAnalysis of VarianceBrainCladribineDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesGadoliniumHumansImmunosuppressive AgentsMagnetic Resonance ImagingMaleMultiple SclerosisSecondary PreventionSeverity of Illness IndexCladribineGadoliniumImmunosuppressive AgentsTablets

Identifiers

What OpenQuestion holds

Textmetadata
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.