Evidence map›Paper›PMID 25889222›Full record

Trial reportArthritis research & therapy2015

Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial.

Patrick Verschueren, Diederik De Cock, Luk Corluy, Rik Joos, Christine Langenaken, Veerle Taelman, Frank Raeman, Isabelle Ravelingien, Klaas Vandevyvere, Jan Lenaerts and 14 more

2 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
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.

NCT01172639 phase4completednot on this map

A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

TypeinterventionalSponsorP. VerschuerenRan2009 to 2015Enrolled400ConditionsRheumatoid ArthritisArmsMethotrexate, Sulfasalazine, Leflunomide, Prednisone
NCT03649061 phase4completednot on this mapstarted 2018, after this paper: background citation

Effectiveness of a Combination of Methotrexate and a Step Down Glucocorticoid Regimen (COBRA-Slim) for Remission Induction in Patients With Early Rheumatoid Arthritis (RA), With or Without Fast Access to 24 Weeks of Tumor Necrosis Factor (TNF) Blockade in Insufficient Responders, a Randomized, Multicenter, Pragmatic Trial

TypeinterventionalSponsorP. VerschuerenRan2018 to 2022Enrolled276ConditionsArthritis, RheumatoidArmsEtanercept 50 MG/ML, Leflunomide 10 milligram (MG)
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 43 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

24 authors at 11 institutions in 2 countries.

Patrick VerschuerenSkeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. patrick.verschueren@uzleuven.be.
Diederik De CockSkeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. diederik.decock@med.kuleuven.be.
Luk CorluyReuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. luk.corluy@skynet.be.
Rik JoosZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. rik.joos@zna.be.
Christine LangenakenReuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. c.langenaken@skynet.be.
Veerle TaelmanHeilig Hart Ziekenhuis Leuven, Naamsestraat 105, 3000, Leuven, Belgium. veerle.taelman@uz.kuleuven.be.
Frank RaemanZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. frank.raeman@zna.be.
Isabelle RavelingienDepartment of Rheumatology, Onze-Lieve-Vrouw Ziekenhuis Aalst, Bloklaan 5, 1730 Asse, Aalst, Belgium. isabelle.ravelingien@olvz-aalst.be.
Klaas VandevyvereAZ Groeninge Hospital Kortrijk, Pres. Kennedylaan 4, 8500, Kortrijk, Belgium. klaas.vandevyvere@azgroeninge.be.
Jan LenaertsReuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. jan.lenaerts@skynet.be.
Elke GeensZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. elke.geens@zna.be.
Piet GeusensReumaClinic Genk & UHasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. piet.geusens@scarlet.be.
Johan VanhoofReumaClinic Genk & UHasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. johanvanhoof@skynet.be.
Anne DurnezAZ Groeninge Hospital Kortrijk, Pres. Kennedylaan 4, 8500, Kortrijk, Belgium. annedurnez@hotmail.com.
Jan RemansReuma-Instituut Genk, Weg naar As 123, 3600, Genk, Belgium. remans.jan@pandora.be.
Bert Vander CruyssenDepartment of Rheumatology, Onze-Lieve-Vrouw Ziekenhuis Aalst, Bloklaan 5, 1730 Asse, Aalst, Belgium. bvcruyssen@hotmail.com.
Els Van EsscheImeldaziekenhuis Bonheiden, Imeldalaan 9, 2820, Bonheiden, Belgium. elsvanessche@hotmail.com.
An SileghemReumaClinic Hasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. annasileghem@gmail.com.
Griet De BrabanterAZ Sint Lucas Brugge, Sint-Lucaslaan 29, 8310, Brugge, Belgium. griet.de.brabanter@telenet.be.
Johan JolyDepartment of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. johan.joly@uzleuven.be.
Kristien Van der ElstDepartment of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. kristien.vanderelst@uzleuven.be.
Sabrina MeyfroidtSkeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. sabrina.meyfroidt@med.kuleuven.be.
Rene WesthovensSkeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. rene.westhovens@uzleuven.be.
CareRA study group
KU Leuven · BEJessa Hospital · BEZiekenhuisnetwerk Antwerpen Stuivenberg · BEAZ Groeninge · BEHasselt University · BEOnze Lieve Vrouwziekenhuis Hospital · BEAZ Sint-Lucas · BEImelda Hospital · BEMaastricht University Medical Centre · NLUniversitair Ziekenhuis Leuven · BEVlaams Instituut voor Biotechnologie · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionConsidering a lack of efficacy data in patients with early rheumatoid arthritis (eRA) presenting without classical markers of poor prognosis, we compared methotrexate (MTX) with or without step-down glucocorticoids in the CareRA trial.

methodsDisease-modifying antirheumatic drug-naïve patients with eRA were stratified into a low-risk group based on prognostic markers that included non-erosiveness, anti-citrullinated protein antibodies and rheumatoid factor negativity and low disease activity (Disease Activity Score in 28 joints based on C-reactive protein (DAS28(CRP)) ≤3.2). Patients were randomized to 15 mg of MTX weekly (MTX with tight step-up (MTX-TSU)) or 15 mg of MTX weekly with prednisone bridging, starting at 30 mg and tapered to 5 mg daily from week 6 (COmbinatie therapie bij Reumatoïde Artritis (COBRA Slim)). A TSU approach was applied. Outcomes assessed were DAS28(CRP)-determined remission, cumulative disease activity, Health Assessment Questionnaire (HAQ) scores and adverse events (AEs) after 16 treatment weeks.

resultsWe analyzed 43 COBRA Slim and 47 MTX-TSU patients and found that 65.1% in the COBRA Slim group and 46.8% in the MTX-TSU group reached remission (P = 0.081). Mean ± standard deviation area under the curve values of DAS28(CRP) were 13.84 ± 4.58 and 11.18 ± 4.25 for the MTX-TSU and COBRA Slim patients, respectively (P = 0.006). More COBRA Slim patients had an HAQ score of 0 (51.2% versus 23.4%, P = 0.006) at week 16. Therapy-related AEs between groups did not differ.

conclusionIn patients with low-risk eRA, MTX with step-down glucocorticoid bridging seems more efficacious than MTX step-up monotherapy, with a comparable number of AEs observed over the first 16 treatment weeks.

trial registrationEU Clinical Trials Register Identifier: EudraCT number 2008-007225-39 . Registered 5 November 2008.

Indexed as

AdultAgedAntirheumatic AgentsArea Under CurveArthritis, RheumatoidBiomarkersC-Reactive ProteinDose-Response Relationship, DrugDrug Administration ScheduleFemaleGlucocorticoidsHumansMaleMethotrexateMiddle AgedPrognosisAntirheumatic AgentsBiomarkersC-Reactive ProteinGlucocorticoidsMethotrexate

Identifiers

PMID25889222
PMCPMC4422551
OpenAlexW1980642334

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.