Evidence map›Paper›PMID 22915624›Full record

Trial reportAnnals of the rheumatic diseases2013

Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial.

Philip G Conaghan, Patrick Durez, Rieke E Alten, Gerd-Rüdiger Burmester, Paul P Tak, Lars Klareskog, Anca Irinel Catrina, Julie DiCarlo, Corine Gaillez, Manuela Le Bars and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00420199 (A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate), which is not on this map. Cited by 28 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 7 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT00420199 phase3completednot on this map

A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate

TypeinterventionalSponsorBristol-Myers SquibbRan2007 to 2010Enrolled50ConditionsActive Rheumatoid ArthritisArmsAbatacept, Placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 7 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Co-stimulation Therapy in Rheumatoid Arthritis: Today and Tomorrow.Current treatment options in rheumatology · 2015
    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

12 authors at 9 institutions in 7 countries.

Philip G ConaghanSection of Musculoskeletal Disease, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK. p.conaghan@leeds.ac.uk
Patrick Durez
Rieke E Alten
Gerd-Rüdiger Burmester
Paul P Tak
Lars Klareskog
Anca Irinel Catrina
Julie DiCarlo
Corine Gaillez
Manuela Le Bars
Xianhuang Zhou
Charles Peterfy
Bristol-Myers Squibb (France) · FRAcademic Medical Center · NLBristol-Myers Squibb (United States) · USCharité - Universitätsmedizin Berlin · DEKarolinska Institutet · SEKarolinska University Hospital · SESchlosspark-Klinik · DEUCLouvain · BEUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis randomised, double-blind, placebo-controlled phase IIIb study evaluated the impact of abatacept on MRI pathology as a primary outcome in methotrexate (MTX)-refractory patients with rheumatoid arthritis.

methodsPatients received intravenous abatacept (∼10 mg/kg) or placebo, on background MTX, for 4 months, followed by an 8-month open-label extension (OLE; all patients received abatacept plus MTX). Patients had 1.5T MRI with intravenous contrast at baseline, Months 4 and 12; wrist synovitis (three locations assessed), and wrist and hand (15 and eight locations assessed, respectively) osteitis and erosion were scored using OMERACT-RAMRIS.

results26/27 abatacept- and 23/23 placebo-randomised patients completed Month 4 and entered the OLE; 26 and 21 completed Month 12. The primary endpoint was not achieved; mean change (SD) from baseline in synovitis was -0.44 (1.47) for abatacept versus 0.52 (1.38) for placebo (p=0.103) at Month 4. For mean change in synovitis adjusted for baseline score (sensitivity analysis), the difference between groups was -0.69, p=0.078. Adjusted mean changes (SE) in osteitis and erosion were -1.94 (0.86) and 0.45 (0.43) for abatacept, and 1.54 (0.90) and 0.95 (0.45) for placebo. Further MRI improvements were observed up to Month 12 for abatacept and from Months 4 to 12 for placebo-treated patients switched to abatacept at Month 4. Clinical efficacy was shown with abatacept and sustained to Month 12.

conclusionsDespite small patient numbers, MRI detected structural and synovial benefit, sustained to Month 12 in abatacept+MTX-treated patients, and improvements in structural and inflammatory outcomes for placebo+MTX-treated patients following addition of abatacept. CLINICAL

trial registrationClinicaltrials.gov NCT00420199.

Indexed as

AbataceptAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug ResistanceDrug SubstitutionDrug Therapy, CombinationFemaleHumansImmunoconjugatesInjections, IntravenousMagnetic Resonance ImagingMaleMethotrexateMiddle AgedOsteitisAbataceptAntirheumatic AgentsImmunoconjugatesMethotrexateDisease ActivityMagnetic Resonance ImagingRheumatoid ArthritisSynovitisT Cells

Identifiers

PMID22915624
PMCPMC3711370
OpenAlexW2105028959

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.