Evidence map›Paper›PMID 22012969›Full record

Trial reportAnnals of the rheumatic diseases2012

Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE.

Paul P Tak, William Rigby, Andrea Rubbert-Roth, Charles Peterfy, Ronald F van Vollenhoven, William Stohl, Emma Healy, Eva Hessey, Mark Reynard, Tim Shaw

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00299104 (A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate), which is not on this map. Cited by 52 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 10 pooled it
6.9field-weighted citation impact, top 3% 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.

NCT00299104 phase3completednot on this map

A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

TypeinterventionalSponsorGenentech, Inc.Ran2006 to 2013Enrolled755ConditionsRheumatoid ArthritisArmsfolate, methotrexate, methylprednisolone, placebo, rituximab
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 10 syntheses or guidelines pooled it, 107 citations in OpenAlex.

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  10. Rituximab for rheumatoid arthritis.The Cochrane database of systematic reviews · 2015
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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

10 authors at 7 institutions in 5 countries.

Paul P TakDivision of Clinical Immunology and Rheumatology, Academic Medical Centre/University of Amsterdam, Amsterdam, The Netherlands. p.p.tak@amc.uva.nl
William Rigby
Andrea Rubbert-Roth
Charles Peterfy
Ronald F van Vollenhoven
William Stohl
Emma Healy
Eva Hessey
Mark Reynard
Tim Shaw
Roche (United Kingdom) · GBDartmouth–Hitchcock Medical Center · USKarolinska Institutet · SESpire Corporation (United States) · USUniversity of Amsterdam · NLUniversity of Cologne · DEUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the IMAGEstudy, rituximab plus methotrexate (MTX) inhibited joint damage and improved clinical outcomes at 1 year in MTX-naïve patients with early active rheumatoid arthritis.

objectiveThe aim of this study was to assess joint damage progression and clinical outcomes over 2 years.

methodsPatients (n=755) were randomised to receive rituximab 2×500 mg+MTX, 2×1000 mg+MTX or placebo+MTX. The placebo-controlled period continued to week 104. Two-year end points were defined as secondary or exploratory and included change in total Genant-modified Sharp score (mTSS), total erosion score and joint space narrowing score from baseline to week 104. Clinical efficacy and physical function end points were also assessed.

resultsAt 2 years, rituximab 2×1000 mg+MTX maintained inhibition of progressive joint damage versus MTX alone (mTSS change 0.41 vs 1.95; p<0.0001 (79% inhibition)), and a higher proportion of patients receiving rituximab 2×1000 mg+MTX had no radiographic progression over 2 years compared with those receiving MTX alone (57% vs 37%; p<0.0001). Contrary to 1-year results, exploratory analysis of rituximab 2×500 mg+MTX at 2 years showed that progressive joint damage was slowed by ∼61% versus placebo+MTX (mTSS, exploratory p=0.0041). Improvements in clinical signs and symptoms and physical function seen after 1 year in rituximab-treated patients versus those receiving placebo were maintained at year 2. Safety profiles were similar between groups.

conclusionsTreatment with rituximab 2×1000 mg+MTX was associated with sustained improvements in radiographic, clinical and functional outcomes over 2 years. Clinical trials.gov identifier NCT00299104.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsArthritis, RheumatoidDisease ProgressionDose-Response Relationship, DrugDrug Therapy, CombinationFollow-Up StudiesHumansMethotrexateMiddle AgedRadiographyRecovery of FunctionAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsMethotrexateRituximab

Identifiers

PMID22012969
PMCPMC3277723
OpenAlexW2135856630

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.