Evidence map›Paper›PMID 33969750›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2022

Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies.

Nicola De Stefano, Maria Pia Sormani, Gavin Giovannoni, Kottil Rammohan, Thomas Leist, Patricia K Coyle, Fernando Dangond, Birgit Keller, Nektaria Alexandri, Andrew Galazka

2 registry-linked trialsAbstract read
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. 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 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing 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.

NCT00213135 phase3completednot on this map

A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

TypeinterventionalSponsorEMD SeronoRan2005 to 2008Enrolled1,326ConditionsMultiple Sclerosis, Relapsing-RemittingArmsCladribine 5.25 mg/kg, Cladribine 3.5 mg/kg, Placebo
NCT00641537 phase3completednot on this map

A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2008 to 2011Enrolled867ConditionsRelapsing-Remitting Multiple SclerosisArmsCladribine, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Switching from anti-CD20 therapies to cladribine and vice versa - Analysis of a German relapsing multiple sclerosis cohort.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Article
  8. Article
  9. Article
  10. Article
  11. Identifying Cladribine prescription pattern in MS: an Italian multicentre study.Therapeutic advances in neurological disorders · 2025
    Article
  12. Article
  13. Cladribine tablets in the new multiple sclerosis era.Therapeutic advances in neurological disorders · 2025
    Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Observational
  20. 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.

Nicola De StefanoDepartment of Neurological and Behavioural Sciences, University of Siena, Siena, Italy/Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.ORCID 0000-0003-4930-7639
Maria Pia SormaniDepartment of Health Sciences, University of Genoa and Ospedale Policlinico San Martino IRCCS, Genoa, Italy.ORCID 0000-0001-6892-104X
Gavin GiovannoniBlizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Kottil RammohanDepartment of Neurology, University of Miami School of Medicine, MS Research Center, Miami, FL, USA.
Thomas LeistDivision of Clinical Neuroimmunology, Jefferson University, Comprehensive MS Center, Philadelphia, PA, USA.
Patricia K CoyleDepartment of Neurology, Stony Brook University, Stony Brook, NY, USA.
Fernando DangondEMD Serono Research & Development Institute, Inc., Billerica, MA, USA.
Birgit KellerMerck KGaA, Darmstadt, Germany.
Nektaria AlexandriMerck KGaA, Darmstadt, Germany.
Andrew GalazkaMerck KGaA, Darmstadt, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study of patients with relapsing-remitting multiple sclerosis, treatment with cladribine tablets 3.5 mg/kg (CladT) significantly reduced the annualised relapse rate (ARR) versus placebo; this effect was sustained in CLARITY Extension, without further treatment.

objectiveTo assess the frequency and severity of relapses in patients treated with CladT versus placebo in CLARITY over 2 years and evaluate the durability of effect in patients who received no further treatment for 2 years in CLARITY Extension.

methodsIn this post hoc analysis, ARRs were calculated for qualifying and all relapses, and qualifying and all severe relapses (i.e. requiring steroid treatment or leading to hospitalisation) in patients treated with CladT (

resultsAt Month 6, Year 1 and Year 2, patients receiving CladT had a significantly lower risk of qualifying or all relapses (all

conclusionThe results show durable efficacy of cladribine tablets 3.5 mg/kg for reducing frequency and severity of relapses in patients with relapsing-remitting multiple sclerosis.CLARITY: NCT00213135; CLARITY Extension: NCT00641537.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingCladribineHumansImmunosuppressive AgentsRecurrenceTabletsCladribineImmunosuppressive AgentsTabletscladribine tabletsdisease-modifying therapyhospitalisationrelapsesRelapsing-remitting multiple sclerosissteroids

Identifiers

PMID33969750
PMCPMC8688984

What OpenQuestion holds

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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.