Evidence map›Paper›PMID 29051829›Full record

ArticleMultiple sclerosis journal - experimental, translational and clinical

The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study.

Mark S Freedman, Thomas P Leist, Giancarlo Comi, Bruce Ac Cree, Patricia K Coyle, Hans-Peter Hartung, Patrick Vermersch, Doris Damian, Fernando Dangond

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Multiple sclerosis journal - experimental, translational and clinical. 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 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
3.3field-weighted citation impact, top 7% of its field
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 map

Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2020 to 2026Enrolled40ConditionsMultiple SclerosisArmsCladribine
NCT04550455 phase4unknown statusnot on this map

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

26 citing papers in PubMed, 40 citations in OpenAlex.

  1. Review
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  5. Cladribine tablets in the new multiple sclerosis era.Therapeutic advances in neurological disorders · 2025
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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

9 authors at 8 institutions in 5 countries.

Mark S FreedmanDepartment of Medicine (Neurology), University of Ottawa and the Ottawa Hospital Research Institute, Canada.
Thomas P LeistDivision of Clinical Neuroimmunology, Thomas Jefferson University, USA.
Giancarlo ComiDepartment of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Italy.
Bruce Ac CreeUniversity of California San Francisco, USA.
Patricia K CoyleStony Brook University, Department of Neurology, USA.
Hans-Peter HartungDepartment of Neurology, Heinrich Heine University, Medical Faculty, Germany.
Patrick VermerschUniversity of Lille, CHU Lille, LIRIC-INSERM U995, FHU Imminent, France.
Doris Damian
Fernando DangondEMD Serono Inc, Billerica, USA.
Heinrich Heine University Düsseldorf · DEInserm · FROno Pharmaceutical (United States) · USStony Brook University · USThomas Jefferson University · USUniversity of California, San Francisco · USUniversity of Ottawa · CAVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple sclerosis (MS) diagnostic criteria have changed since the ORACLE-MS study was conducted; 223 of 616 patients (36.2%) would have met the diagnosis of MS vs clinically isolated syndrome (CIS) using the newer criteria.

objectiveThe objective of this paper is to assess the effect of cladribine tablets in patients with a first clinical demyelinating attack fulfilling newer criteria (McDonald 2010) for MS vs CIS.

methodsA post hoc analysis for subgroups of patients retrospectively classified as fulfilling or not fulfilling newer criteria at the first clinical demyelinating attack was conducted.

resultsCladribine tablets 3.5 mg/kg (

conclusionsRegardless of the criteria used to define CIS or MS, 3.5 mg/kg cladribine tablets are effective in patients with a first clinical demyelinating attack.

Indexed as

Cladribine tabletsclinically isolated syndromeconversion to clinically definite multiple sclerosisearly multiple sclerosisefficacyMcDonald 2010 criteria

Identifiers

PMID29051829
PMCPMC5637982
OpenAlexW2761038804

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.