Evidence map›Paper›PMID 26361879›Full record

Trial reportRheumatology (Oxford, England)2016

Two-year radiographic and clinical outcomes from the Canadian Methotrexate and Etanercept Outcome study in patients with rheumatoid arthritis.

Edward C Keystone, Janet E Pope, J Carter Thorne, Melanie Poulin-Costello, Krystene Phan-Chronis, Andrew Vieira, Boulos Haraoui, CAMEO Investigators

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

Trial report in Rheumatology (Oxford, England), 2016. 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 10 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 4 pooled it
0.8field-weighted citation impact, top 25% 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

10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
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  4. Guideline
  5. Article
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  7. Observational
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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

8 authors at 4 institutions in 2 countries.

Edward C KeystoneMt Sinai Hospital, Department of Rheumatology, Toronto.
Janet E PopeSt Joseph's Health Centre, Rheumatology Centre, London.
J Carter ThorneSouthlake Regional Health Centre, Division of Rheumatology, Newmarket.
Melanie Poulin-CostelloAmgen Canada Inc., Biostatistics.
Krystene Phan-ChronisAmgen Canada Inc., Medical Communications.
Andrew VieiraAmgen Canada Inc., Medical Development, Mississauga, ON and.
Boulos Haraoui
CAMEO Investigators
Amgen (Canada) · CASinai Hospital · USSouthlake Regional Health Center · CASt Joseph's Health Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate radiographic and clinical outcomes up to 24 months in patients with RA enrolled in the Canadian Methotrexate and Etanercept Outcome study.

methodsIn this open-label non-inferiority trial, patients with inadequate response to MTX received etanercept plus MTX for 6 months and then were randomized to either etanercept monotherapy or continued etanercept plus MTX until 24 months. Radiographic data were analysed using the modified total Sharp score (mTSS), joint space narrowing and erosion scores. Secondary outcomes included the 28-joint DAS with ESR (DAS28-ESR), Simplified Disease Activity Index, Clinical Disease Activity Index, HAQ Disability Index (HAQ-DI) and safety.

resultsTwo hundred five of 258 patients enrolled were randomized (98 etanercept, 107 etanercept plus MTX). At month 24, the mean increase from baseline to month 24 for the etanercept and etanercept plus MTX arms, respectively, for the mTSS were 0.4 (s.d. 1.9) and 0.0 (s.d. 1.4); for joint space narrowing, 0.1 (s.d. 0.6) and 0.0 (s.d. 0.7) and for erosion, 0.3 (s.d. 1.5) and 0.0 (s.d. 1.0). At month 24, the mean increase from month 6 mean scores/count increases for DAS28-ESR were 0.56 (s.d. 1.26) and 0.08 (s.d. 1.50); for Simplified Disease Activity Index, 4.7 (s.d. 13.1) and 0.9 (s.d. 12.5); for Clinical Disease Activity Index, 4.1 (s.d. 12.3) and 1.0 (s.d. 12.3) and for HAQ-DI, 0.20 (s.d. 0.45) and 0.02 (s.d. 0.54). Patients with DAS28-ESR low disease activity (LDA)/remission at month 6 had numerically better outcomes at month 24 than patients with moderate to high disease activity at month 6. In patients with LDA/remission at month 6, outcomes were similar at month 24 between etanercept monotherapy and etanercept plus MTX, whereas patients with moderate to high disease activity at month 6 had numerically better outcomes with etanercept plus MTX than etanercept at month 24. There were no new safety signals and serious adverse events were not different between groups.

conclusionThese results support the possibility of discontinuing MTX in patients who have tolerability issues with MTX if they achieve LDA/remission.

trial registrationClinicalTrials.gov (https://clinicaltrials.gov/; NCT00654368).

Indexed as

Arthritis, RheumatoidEtanerceptMethotrexateAntirheumatic AgentsCanadaDisease ProgressionDose-Response Relationship, DrugDrug Therapy, CombinationFollow-Up StudiesHumansInjections, SubcutaneousRadiographySeverity of Illness IndexTime FactorsTreatment OutcomeAntirheumatic AgentsEtanerceptMethotrexateclinical outcomesetanerceptmethotrexateradiographic outcomesrandomized trialrheumatoid arthritis

Identifiers

PMID26361879
PMCPMC4710802
OpenAlexW2173611899

What OpenQuestion holds

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LicenceCC BY-NC
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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.