Evidence map›Paper›PMID 20530322›Full record

Trial reportNeurology2010

Rituximab add-on therapy for breakthrough relapsing multiple sclerosis: a 52-week phase II trial.

R T Naismith, L Piccio, J A Lyons, J Lauber, N T Tutlam, B J Parks, K Trinkaus, S K Song, A H Cross

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Neurology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04466150 (Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset), which is not on this map. Cited by 93 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 6 pooled it
9.9field-weighted citation impact, top 1% 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.

NCT04466150 phase4active not recruitingnot on this mapstarted 2020, after this paper: background citation

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2027Enrolled30ConditionsRelapsing Multiple Sclerosis, Clinically Isolated SyndromeArmsOcrelizumab
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 6 syntheses or guidelines pooled it, 216 citations in OpenAlex.

  1. Rituximab for people with multiple sclerosis.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Rituximab for people with multiple sclerosis.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Pooled it
  5. Rituximab for relapsing-remitting multiple sclerosis.The Cochrane database of systematic reviews · 2013
    Pooled it
  6. Pooled it
  7. Trial
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Ofatumumab in pediatric multiple sclerosis: a case series.Therapeutic advances in neurological disorders · 2025
    Article
  15. Article
  16. Article
  17. Review
  18. Observational
  19. Observational
  20. What Have Failed, Interrupted, and Withdrawn Antibody Therapies in Multiple Sclerosis Taught Us?Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review

33 more citing papers are in PubMed but not listed here.

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 1 institution in 1 country.

R T NaismithDepartment of Neurology, Washington University, St. Louis, MO, USA. naismithr@neuro.wustl.edu
L Piccio
J A Lyons
J Lauber
N T Tutlam
B J Parks
K Trinkaus
S K Song
A H Cross
Oklahoma State University Center for Health Sciences · US

Funding

Washington University Institute of Clinical and Translational Sciences (UL1)UL1RR024992 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$45.4M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Diffusion Imaging of Axonal Loss in the Optic NervesK23NS052430 · NINDS · WASHINGTON UNIVERSITY · PI NAISMITH, ROBERT T · 2007 to 2011
$755k
A PHASE ll TRIAL OF RITUXAN IN MULTIPLE SCLEROSISK24RR017100 · NCRR · WASHINGTON UNIVERSITY · PI CROSS, DOROTHY ANNE · 2004 to 2007
$347k
NCATS NIH HHS UL1 TR000448NCI NIH HHS CO6 RR020092NCRR NIH HHS K12RR02324902NCRR NIH HHS K24 RR017100NCRR NIH HHS RR024992NCRR NIH HHS UL1 RR024992NINDS NIH HHS K23NS052430-01A1
6 · The paper itself

Abstract

objectiveB cells and the humoral immune system have been implicated in the pathogenesis of multiple sclerosis (MS). This study sought to evaluate the efficacy, safety, and tolerability of add-on therapy with rituximab, a monoclonal antibody that depletes circulating B cells, in subjects with relapsing MS with breakthrough disease defined by clinical and MRI activity (Class III evidence).

methodsThirty subjects with a relapse within the past 18 months despite use of an injectable disease-modifying agent, and with at least 1 gadolinium-enhancing (GdE) lesion on any of 3 pretreatment MRIs, received rituximab administered at 375 mg/m(2) weekly x 4 doses. Three monthly posttreatment brain MRI scans were obtained beginning 12 weeks after the first infusion. Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) were obtained at baseline and throughout the posttreatment follow-up.

resultsGdE lesions were reduced after treatment with rituximab, with 74% of posttreatment MRI scans being free of GdE activity compared with 26% free of GdE activity at baseline (p < 0.0001). Median GdE lesions were reduced from 1.0 to 0, and mean number was reduced from 2.81 per month to 0.33 after treatment (88% reduction). MSFC improved as well (p = 0.02). EDSS remained stable.

conclusionRituximab add-on therapy was effective based upon blinded radiologic endpoints in this phase II study. In combination with standard injectable therapies, rituximab was well-tolerated with no serious adverse events. B-cell-modulating therapy remains a potential option for treatment of patients with relapsing MS with an inadequate response to standard injectable therapies. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that add-on rituximab reduces gadolinium-enhancing brain lesions in multiple sclerosis.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedB-LymphocytesDisability EvaluationDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesGadoliniumHumansImmunologic FactorsMagnetic Resonance ImagingMaleAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedGadoliniumImmunologic FactorsRituximab

Identifiers

PMID20530322
PMCPMC2882224
OpenAlexW2083565083

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.