Evidence map›Paper›PMID 30635477›Full record

Trial reportNeurology2019

Rituximab vs placebo induction prior to glatiramer acetate monotherapy in multiple sclerosis.

Justin M Honce, Kavita V Nair, Stefan Sillau, Brooke Valdez, Augusto Miravalle, Enrique Alvarez, Teri Schreiner, John R Corboy, Timothy L Vollmer

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01569451 (A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
3.5field-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.

NCT01569451 phase2completednot on this map

A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis

TypeinterventionalSponsorUniversity of Colorado, DenverRan2012 to 2015Enrolled53ConditionsMultiple SclerosisArmsRituximab, Glatiramer Acetate, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 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. Discontinuation of ocrelizumab in multiple sclerosis: reoccurrence of disease activity.Journal of neurology, neurosurgery, and psychiatry · 2026
    Observational
  5. Review
  6. Article
  7. Review
  8. Article
  9. Evolution of Anti-B Cell Therapeutics in Autoimmune Neurological Diseases.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  10. 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
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Rituximab, MS, and pregnancy.Neurology(R) neuroimmunology & neuroinflammation · 2020
    Article
  18. Glatiramer acetate immune modulates B-cell antigen presentation in treatment of MS.Neurology(R) neuroimmunology & neuroinflammation · 2020
    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

9 authors at 1 institution in 1 country.

Justin M HonceFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.ORCID 0000-0003-3799-2624
Kavita V NairFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.ORCID 0000-0002-2442-2537
Stefan SillauFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.ORCID 0000-0002-8691-3139
Brooke ValdezFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.
Augusto MiravalleFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.
Enrique AlvarezFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.ORCID 0000-0001-5854-9643
Teri SchreinerFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.
John R CorboyFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado.ORCID 0000-0003-4169-1461
Timothy L VollmerFrom the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; and Department of Neurology (A.M.), University of Florida, Gainesville. Dr. Miravalle is currently at Advanced Neurology of Colorado, Fort Collins, Colorado. timothy.vollmer@ucdenver.edu.ORCID 0000-0003-2750-9985
University of Colorado Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine whether rituximab induction followed by glatiramer acetate (GA) monotherapy is more effective than GA alone for the treatment of relapsing multiple sclerosis with active disease.

methodsThis was a single-center, double-blind, placebo-controlled study. Fifty-five participants were randomly assigned (1:1 ratio) to either rituximab (R-GA) or placebo (P-GA) induction, followed by GA therapy initiated in all participants. Participants were followed up to 3 years. The primary endpoint was the number of participants with no evidence of disease activity (NEDA): those without relapse, new MRI lesions, and sustained change in disability.

resultsTwenty-eight and 27 participants received rituximab and placebo induction, respectively, with one participant in each arm withdrawing before 6-month MRI. There were no significant differences in baseline characteristics. At end of study, 44.44% of R-GA participants demonstrated NEDA vs 19.23% of P-GA participants (

conclusionsInduction therapy with rituximab followed by GA may provide superior efficacy in the short term than GA alone in relapsing multiple sclerosis, but this benefit appears to wane within the study period. Larger studies are needed to assess sustainability of results. CLINICALTRIALSGOV IDENTIFIER: NCT01569451.

Indexed as

AdultBrainDemyelinating DiseasesDouble-Blind MethodFemaleGlatiramer AcetateHumansImmunologic FactorsImmunosuppressive AgentsInduction ChemotherapyMagnetic Resonance ImagingMaintenance ChemotherapyMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingRituximabGlatiramer AcetateImmunologic FactorsImmunosuppressive AgentsRituximab

Identifiers

PMID30635477
PMCPMC6382366
OpenAlexW2908974689

What OpenQuestion holds

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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.