Evidence map›Paper›PMID 27481207›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2017

ACCLAIM: A randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis.

Samia J Khoury, James Rochon, Linna Ding, Margie Byron, Kristin Ryker, Patti Tosta, Wendy Gao, Mark S Freedman, Douglas L Arnold, Peter H Sayre and 2 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01116427 (A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple Sclerosis), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT01116427 phase2completednot on this map

A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple Sclerosis

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2015Enrolled65ConditionsMultiple Sclerosis, Relapsing-RemittingArmsabatacept, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Article
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  9. Article
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  11. Article
  12. Silencing Immune Dialogue in Multiple Sclerosis.The New England journal of medicine · 2024
    Article
  13. Review
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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

12 authors at 6 institutions in 3 countries.

Samia J KhouryPartners Multiple Sclerosis Center, Brigham and Women's Hospital, Boston, MA, USA/Abu Haidar Neuroscience Institute, American University of Beirut, Beirut, Lebanon.
James RochonRho, Inc., Chapel Hill, NC, USA.
Linna DingDivision of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
Margie ByronRho, Inc., Chapel Hill, NC, USA.
Kristin RykerImmune Tolerance Network, San Francisco, CA, USA.
Patti TostaImmune Tolerance Network, San Francisco, CA, USA.
Wendy GaoDivision of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
Mark S FreedmanUniversity of Ottawa, Ottawa, ON, Canada.
Douglas L ArnoldNeuroRx Research and McGill University, Montreal, QC, Canada.
Peter H SayreImmune Tolerance Network, San Francisco, CA, USA.
Dawn E SmilekImmune Tolerance Network, San Francisco, CA, USA.
ACCLAIM Study Group
Immune Tolerance Network · USNational Institute of Allergy and Infectious Diseases · USRho (United States) · USAmerican University of Beirut · LBNeuroRx Research (Canada) · CAUniversity of Ottawa · CA

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
IMMUNE TOLERANCE NETWORK-266015416-266015416N01AI015416 · NIAID · REGENTS OF THE UNIVERSITY OF C · PI BLUESTONE, JEFFREY A · 2002 to 2006
–
NIAID NIH HHS HHSN272200800029CNIAID NIH HHS N01 AI015416NIAID NIH HHS UM1 AI109565NIAID NIH HHS UM2 AI117870
6 · The paper itself

Abstract

backgroundCostimulatory blockade of T lymphocytes with the CTLA4-Ig fusion protein abatacept could be an effective treatment for the immune-mediated neuroinflammatory disease relapsing-remitting multiple sclerosis (RRMS).

objectiveTo evaluate efficacy and safety of abatacept in RRMS.

methodsACCLAIM (A Cooperative Clinical Study of Abatacept in Multiple Sclerosis) was a Phase II, randomized, double-blind, placebo-controlled, multi-center trial. In all, 65 of 123 planned participants with RRMS were randomized to monthly intravenous infusions of abatacept or placebo for 24 weeks in a 2:1 ratio, switched to the opposite treatment at 28 weeks, and received their final dose of study medication at 52 weeks. Enrollment was closed early due to slow accrual. The primary endpoint was the mean number of new gadolinium-enhancing (Gd+) lesions obtained on magnetic resonance imaging (MRI) scans performed every 4 weeks.

resultsNo statistically significant differences were observed in mean number of new Gd+ MRI lesions between the abatacept and placebo groups. No statistically significant differences were observed in other MRI and clinical parameters of RRMS disease activity. Abatacept was well tolerated.

conclusionThe ACCLAIM study did not demonstrate efficacy of abatacept in reducing the number of new Gd+ MRI lesions, or clinical measures of disease activity in RRMS.

Indexed as

AbataceptAdultDouble-Blind MethodFemaleGadoliniumHumansInterferon-betaMagnetic Resonance ImagingMaleMultiple Sclerosis, Relapsing-RemittingTreatment OutcomeAbataceptGadoliniumInterferon-betaAbataceptautoimmune diseasesclinical trialcostimulatory and inhibitory T-cell receptorsgadoliniumintervention studymagnetic resonance imagingmultiple sclerosisrelapsing-remitting

Identifiers

PMID27481207
PMCPMC5288398
OpenAlexW2500435921

What OpenQuestion holds

Textmetadata
LicenceTDM
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.