Evidence map›Paper›PMID 32901316›Full record

Trial reportJournal of neurology2021

Intrathecal treatment trial of rituximab in progressive MS: results after a 2-year extension.

Joakim Bergman, Joachim Burman, Tommy Bergenheim, Anders Svenningsson

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 24% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Periventricular gradient of TNeuroImage. Clinical · 2022
    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

4 authors at 3 institutions in 2 countries.

Joakim BergmanDepartment of Clinical Science, Umeå University, Umeå, Sweden.
Joachim BurmanDepartment of Neurosciences, Uppsala University, Uppsala, Sweden.
Tommy BergenheimDepartment of Clinical Science, Umeå University, Umeå, Sweden.
Anders SvenningssonDepartment of Clinical Science, Umeå University, Umeå, Sweden. anders.svenningsson@ki.se.ORCID http://orcid.org/0000-0003-0663-2220
Umeå University · SEDanderyds sjukhus · SEUppsala University · SE

Funding

National Multiple Sclerosis Society PA 0185
6 · The paper itself

Abstract

objectivesTo evaluate the effect of intrathecally (IT) delivered rituximab as a therapeutic intervention for progressive multiple sclerosis (PMS) during a 3-year follow-up period.

methodsParticipants of a 1-year open-label phase 1b study of IT delivered rituximab to patients with PMS were offered extended treatment with follow-up for an additional 2 years. During the extension phase, treatment with 25 mg rituximab was administered every 6 months via a subcutaneous Ommaya reservoir connected to the right frontal horn with a ventricular catheter.

resultsMild to moderate vertigo and nausea occurred in 4 out of 14 participants as temporary adverse events associated with IT rituximab infusion. During the entire 3-year period, two cases of low-virulent bacterial meningitis occurred, which were successfully treated. Walking speed deteriorated significantly during the study.

conclusionsIT administration of rituximab via a ventricular catheter was well tolerated. Considering the meningitis cases, the risk of infection was not negligible. The continued loss of walking speed indicates that IT rituximab was not able to stop disease progression. CLASSIFICATION OF EVIDENCE: This study provides class IV evidence that intraventricularly administered rituximab in progressive MS is associated with a risk for bacterial meningitis and does not halt disease progression. EU CLINICAL TRIAL REGISTER: EudraCT; 2008-002626-11 and 2012-000721-53.

Indexed as

Immunologic FactorsMultiple Sclerosis, Chronic ProgressiveDisease ProgressionHumansRituximabImmunologic FactorsRituximabClinical trialIntrathecalMultiple sclerosisProgressive MSRituximabTreatment

Identifiers

PMID32901316
PMCPMC7880973
OpenAlexW3084290826

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.