Evidence map›Paper›PMID 34984839›Full record

Trial reportCNS neuroscience & therapeutics2022

Results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids.

Daniel Wynn, Lawrence Goldstick, William Bauer, Enxu Zhao, Eva Tarau, Jeffrey A Cohen, Derrick Robertson, Aaron Miller

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in CNS neuroscience & therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 23% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. ActharClinical drug investigation · 2023
    Review
  4. Review
  5. Acthar Gel Inhibits the Activation of CD4Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research · 2023
    Article
  6. Review
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

8 authors at 8 institutions in 2 countries.

Daniel WynnConsultants in Neurology, Multiple Sclerosis Center, Northbrook, Illinois, USA.
Lawrence GoldstickUniversity of Cincinnati Waddell Center for Multiple Sclerosis, Cincinnati, Ohio, USA.
William BauerDepartment of Neurosciences, University of Toledo, Toledo, Ohio, USA.
Enxu ZhaoMallinckrodt Pharmaceuticals, Hampton, New Jersey, USA.
Eva TarauMallinckrodt Pharmaceuticals, Hampton, New Jersey, USA.
Jeffrey A CohenMellen MS Center, Cleveland Clinic, Cleveland, Ohio, USA.
Derrick RobertsonDepartment of Neurology, University of South Florida, Tampa, Florida, USA.
Aaron MillerIcahn School of Medicine at Mount Sinai Hospital, New York, New York, USA.
Cleveland Clinic · USConsultants in Neurology · USIcahn School of Medicine at Mount Sinai · USMallinckrodt (Ireland) · IEMallinckrodt (United States) · USUniversity of Cincinnati · USUniversity of South Florida · USUniversity of Toledo · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAbout 20%-35% of multiple sclerosis (MS) patients fail to respond to high-dose corticosteroids during a relapse. Repository corticotropin injection (RCI, Acthar

aimsThe study objective was to determine the efficacy and safety of RCI in patients with MS relapse that inadequately responded to corticosteroids. This was a multicenter, double-blind, placebo-controlled study. Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days. Assessments included improvements on the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), Clinical Global Impression of Improvement (CGI-I), and adverse events (AEs).

resultsEighteen patients received RCI, and 17 received placebo. A greater proportion of EDSS responders was observed in the RCI group at Day 7, 21, and 42 compared with the placebo group. Qualitative CGI-I showed that more patients receiving RCI were much improved or very much improved than with placebo. No meaningful differences were observed between treatment groups for MSIS-29. No serious AEs or deaths were reported.

conclusionRCI is safe and effective for MS relapse patients who do not respond to high-dose corticosteroids.

Indexed as

Multiple SclerosisAdrenal Cortex HormonesAdrenocorticotropic HormoneChronic DiseaseDouble-Blind MethodHumansRecurrenceAdrenal Cortex HormonesAdrenocorticotropic HormoneActhar Gelclinical trialmultiple sclerosisrelapserepository corticotropin injection

Identifiers

PMID34984839
PMCPMC8841301
OpenAlexW4205462144

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.