Evidence map›Paper›PMID 19933744›Full record

Trial reportAnnals of the rheumatic diseases2010

Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial).

P Emery, P Durez, M Dougados, C W Legerton, J-C Becker, G Vratsanos, H K Genant, C Peterfy, P Mitra, S Overfield and 2 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00124449 (A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis), which is not on this map. Cited by 90 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 5 pooled it
19.0field-weighted citation impact, top 1% 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.

NCT00124449 phase2completednot on this map

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

TypeinterventionalSponsorBristol-Myers SquibbRan2005 to 2008Enrolled56ConditionsArthritis, RheumatoidArmsAbatacept, placebo
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 5 syntheses or guidelines pooled it, 256 citations in OpenAlex.

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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 4 countries.

P EmerySection of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds. p.emery@leeds.ac.uk [corrected]
P Durez
M Dougados
C W Legerton
J-C Becker
G Vratsanos
H K Genant
C Peterfy
P Mitra
S Overfield
K Qi
R Westhovens
Bristol-Myers Squibb (United States) · USHôpital Cochin · FRUCLouvain · BEUniversitair Ziekenhuis Leuven · BEUniversity of California, San Francisco · USUniversity of Leeds · GB

Funding

Arthritis Research UK 18475
6 · The paper itself

Abstract

backgroundSeveral agents provide treatment for established rheumatoid arthritis (RA), but a crucial therapeutic goal is to delay/prevent progression of undifferentiated arthritis (UA) or very early RA.

objectiveTo determine the impact of T-cell costimulation modulation in patients with UA or very early RA.

methodsIn this double-blind, phase II, placebocontrolled, 2-year study, anti-cyclic citrullinated peptide (CCP)2-positive patients with UA (not fulfilling the ACR criteria for RA) and clinical synovitis of two or more joints were randomised to abatacept ( approximately 10 mg/kg) or placebo for 6 months; the study drug was then terminated. The primary end point was development of RA (by ACR criteria) at year 1. Patients were monitored by radiography, MRI, CCP2, rheumatoid factor and 28 joint count Disease Activity Score (DAS28) over 2 years.

resultsAt year 1, 12/26 (46%) abatacept-treated versus 16/24 (67%) placebo-treated patients developed RA (difference (95% CI) -20.5% (-47.4% to 7.8%)). Adjusted mean changes from baseline to year 1 in Genant-modified Sharp radiographic scores for abatacepttreated versus placebo-treated patients, respectively, were 0 versus 1.1 for total score, and 0 versus 0.9 for erosion score. Mean changes from baseline to year 1 in MRI erosion, osteitis and synovitis scores were 0, 0.2 and 0.2, respectively, versus 5.0, 6.7 and 2.3 in the abatacept versus placebo groups. Safety was comparable between groups; serious adverse events occurred in one patient (3.6%) in each group.

conclusionAbatacept delayed progression of UA/very early RA in some patients. An impact on radiographic and MRI inhibition was seen, which was maintained for 6 months after treatment stopped. This suggests that it is possible to alter the progression of RA by modulating T-cell responses at a very early stage of disease. Trial registration number NCT00124449.

Indexed as

AbataceptAdultAntirheumatic AgentsArthritisAutoantibodiesBiomarkersEpidemiologic MethodsFemaleHumansImmunity, CellularImmunoconjugatesImmunosuppressive AgentsMalePeptides, CyclicRheumatoid FactorSynovitisAbataceptAntirheumatic AgentsAutoantibodiesBiomarkerscyclic citrullinated peptideImmunoconjugatesImmunosuppressive AgentsPeptides, CyclicRheumatoid Factor

Identifiers

PMID19933744
PMCPMC2927615
OpenAlexW2128713459

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.