Evidence map›Paper›PMID 25355728›Full record

Trial reportAnnals of the rheumatic diseases2016

MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study.

Charles Peterfy, Paul Emery, Paul P Tak, Mikkel Østergaard, Julie DiCarlo, Kati Otsa, Federico Navarro Sarabia, Karel Pavelka, Marie-Agnes Bagnard, Lykke Hinsch Gylvin and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00578305 (A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
4.8field-weighted citation impact, top 5% 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.

NCT00578305 phase3completednot on this map

A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

TypeinterventionalSponsorHoffmann-La RocheRan2007 to 2013Enrolled185ConditionsRheumatoid ArthritisArmsRituximab, Placebo, Methylprednisolone, Methotrexate, Folic acid or folate
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 59 citations in OpenAlex.

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  19. Observational
  20. Rituximab in autoimmune diseases.Australian prescriber · 2016
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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 6 countries.

Charles PeterfySpire Sciences, Inc., Boca Raton, Florida, USA.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Paul P Tak*Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands; *Current address also: University of Cambridge, Cambridge, UK and GlaxoSmithKline, Stevenage, UK.
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital. University of Copenhagen, Copenhagen, Denmark.
Julie DiCarloSpire Sciences, Inc., Boca Raton, Florida, USA.
Kati OtsaTallinn Central Hospital, Tallinn, Estonia.
Federico Navarro SarabiaHospital Universitario, Seville, Spain.
Karel PavelkaCharles University, Prague, Czech Republic.
Marie-Agnes BagnardF Hoffmann-La Roche Ltd, Basel, Switzerland.
Lykke Hinsch GylvinF Hoffmann-La Roche Ltd, Basel, Switzerland.
Corrado BernasconiF Hoffmann-La Roche Ltd, Basel, Switzerland.
Annarita GabrieleF Hoffmann-La Roche Ltd, Basel, Switzerland.
Roche (Switzerland) · CHAcademic Medical Center · NLCharles University · CZEast Tallinn Central Hospital · EENIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversity of Copenhagen · DK

Funding

Versus Arthritis 18475
6 · The paper itself

Abstract

objectiveTo evaluate changes in structural damage and joint inflammation assessed by MRI following rituximab treatment in a Phase 3 study of patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) who were naive to biological therapy.

methodsPatients were randomised to receive two infusions of placebo (n=63), rituximab 500 mg (n=62), or rituximab 1000 mg (n=60) intravenously on days 1 and 15. MRI scans and radiographs of the most inflamed hand and wrist were acquired at baseline, weeks 12 (MRI only), 24 and 52. The primary end point was the change in MRI erosion score from baseline at week 24.

resultsPatients treated with rituximab demonstrated significantly less progression in the mean MRI erosion score compared with those treated with placebo at weeks 24 (0.47, 0.18 and 1.60, respectively, p=0.003 and p=0.001 for the two rituximab doses vs placebo) and 52 (-0.30, 0.11 and 3.02, respectively; p<0.001 and p<0.001). Cartilage loss at 52 weeks was significantly reduced in the rituximab group compared with the placebo group. Other secondary end points of synovitis and osteitis improved significantly with rituximab compared with placebo as early as 12 weeks and improved further at weeks 24 and 52.

conclusionsThis study demonstrated that rituximab significantly reduced erosion and cartilage loss at week 24 and week 52 in MTX-inadequate responder patients with active RA, suggesting that MRI is a valuable tool for assessing inflammatory and structural damage in patients with established RA receiving rituximab. TRIAL REGISTRATION NUMBER: NCT00578305.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidCartilage, ArticularDisease ProgressionDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedRadiographyRituximabSeverity of Illness IndexTreatment OutcomeAntirheumatic AgentsRituximabDMARDs (biologic)InflammationMagnetic Resonance ImagingRheumatoid Arthritis

Identifiers

PMID25355728
PMCPMC4717395
OpenAlexW2148170354

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.