Evidence map›Paper›PMID 23979914›Full record

Trial reportAnnals of the rheumatic diseases2014

The Canadian methotrexate and etanercept outcome study: a randomised trial of discontinuing versus continuing methotrexate after 6 months of etanercept and methotrexate therapy in rheumatoid arthritis.

Janet E Pope, Boulos Haraoui, J Carter Thorne, Andrew Vieira, Melanie Poulin-Costello, Edward C Keystone

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

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00654368 (Canadian Methotrexate and Etanercept Outcome Study), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
4.0field-weighted citation impact, top 6% 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.

NCT00654368 phase4completednot on this map

Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)

TypeinterventionalSponsorAmgenRan2008 to 2013Enrolled258ConditionsRheumatoid ArthritisArmsEtanercept, Methotrexate
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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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

6 authors at 4 institutions in 2 countries.

Janet E PopeDivision of Rheumatology, Department of Medicine, The University of Western Ontario, St Joseph's Health Centre, London, Ontario, Canada.
Boulos HaraouiDepartment of Rheumatology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.
J Carter ThorneSouthlake Regional Health Centre, Newmarket, Ontario, Canada.
Andrew VieiraAmgen Canada Inc., Mississauga, Ontario, Canada.
Melanie Poulin-CostelloAmgen Canada Inc., Mississauga, Ontario, Canada.
Edward C KeystoneDepartment of Rheumatology, Mount Sinai Hospital, Rebecca MacDonald Centre For Arthritis & Autoimmune Diseases, Toronto, Ontario, Canada.
Amgen (United States) · USCentre Hospitalier de l’Université de Montréal · CAMount Sinai Hospital · CASouthlake Regional Health Center · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine if withdrawing methotrexate (MTX) after 6 months of combination etanercept (ETN)+MTX, in MTX-inadequate responders with active rheumatoid arthritis (RA), is non-inferior to continuing ETN+MTX.

methodsTumour necrosis factor-inhibitor naïve RA patients with disease activity score 28 (DAS28)≥3.2, swollen joint count≥3, despite stable MTX, were treated with ETN+MTX for 6 months, followed by randomisation to either continue ETN+MTX or switch to ETN monotherapy for an additional 18 months. The primary endpoint was change in DAS28 from 6-month randomisation to 12 months. The non-inferiority margin of change in DAS28 was 0.6, with prespecified analyses (DAS28<3.2 vs DAS28≥3.2).

results205 patients were randomised. DAS28 was stable in patients on ETN+MTX and increased slightly in patients on ETN monotherapy from 6 to 12 months. Non-inferiority was not achieved, with an adjusted difference of 0.4 (0.1 to 0.7) between the ETN and the ETN+MTX groups, for the month 6-12 change in DAS28. However, patients who achieved low disease activity (LDA; DAS28<3.2) at 6 months had a similar disease activity at 12 months, whether on monotherapy or combination therapy (DAS28 change 0.7 ETN vs 0.57 ETN+MTX, p=0.8148). Conversely, for patients who did not reach LDA at 6 months, those on ETN monotherapy had increased disease activity at 12 months, while disease activity continued to decrease for patients on combination therapy, at 12 months (DAS28 change 0.4 ETN vs -0.4 ETN+MTX, p=0.0023).

conclusionsNon-inferiority was not achieved. Withdrawing MTX after 6 months of continuation ETN+MTX in MTX inadequate responders did not yield the same degree of improvement between 6 and 12 months compared with continuing ETN+MTX.

trial registrationClinicalTrials.gov-NCT00654368.

Indexed as

Withholding TreatmentAdultAgedAntirheumatic AgentsArthritis, RheumatoidCanadaDrug Therapy, CombinationEtanerceptFemaleHumansImmunoglobulin GMaleMethotrexateMiddle AgedReceptors, Tumor Necrosis FactorTime FactorsAntirheumatic AgentsEtanerceptImmunoglobulin GMethotrexateReceptors, Tumor Necrosis FactorAnti-TNFDMARDs (biologic)MethotrexateRheumatoid Arthritis

Identifiers

PMID23979914
PMCPMC4251190
OpenAlexW2141953337

What OpenQuestion holds

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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.