Evidence map›Paper›PMID 26289076›Full record

Trial reportTrials2015

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

Caridad Pontes, Jordi Gratacós, Ferran Torres, Cristina Avendaño, Jesús Sanz, Antoni Vallano, Xavier Juanola, Eugenio de Miguel, Raimon Sanmartí, Gonzalo Calvo

Open access · goldAbstract readComparative StudyMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.5field-weighted citation impact, top 31% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
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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 6 institutions in 1 country.

Caridad PontesClinical Pharmacology Unit, Hospital de Sabadell. Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, Sabadell (Barcelona), Spain. cpontes@tauli.cat.
Jordi GratacósRheumatology Service, Hospital de Sabadell. Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, 08208, Sabadell (Barcelona), Spain. jgratacosmas@gmail.com.
Ferran TorresBiostatistics and Data Management Platform, IDIBAPS, Hospital Clínic, Biostatistics Unit. Faculty of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain. ferran.torres@uab.es.
Cristina AvendañoClinical Pharmacology Service. Hospital Puerta de Hierro-Majadahonda, Madrid, Spain. cavendano@salud.madrid.org.
Jesús SanzRheumatology Service, Hospital Puerta de Hierro-Majadahonda, Madrid, Spain. jesussanzsanz4@gmail.com.
Antoni VallanoClinical Pharmacology Service, Hospital Universitario de Bellvitge - IDIBELL- Universitat de Barcelona, Bellvitge (Barcelona), Spain. avallano@bellvitgehospital.cat.
Xavier JuanolaRheumatology Service, Hospital Universitario de Bellvitge - IDIBELL- Universitat de Barcelona, Bellvitge (Barcelona), Spain. x.juanola@bellvitgehospital.cat.
Eugenio de MiguelRheumatology Service, Hospital Universitario La Paz, Madrid, Spain. eugenio.demiguel@gmail.com.
Raimon SanmartíRheumatology Service, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain. SANMARTI@clinic.ub.es.
Gonzalo CalvoClinical Pharmacology Service, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain. gcalvo@clinic.ub.es.
Universitat Autònoma de Barcelona · ESHospital Clínic de Barcelona · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Universitario La Paz · ESInstitut d'Investigació Biomédica de Bellvitge · ESUniversitat de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. METHODS/

designTo address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. DISCUSSION: The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers.

trial registrationEudraCT 2011-005871-18 (21 December 2011).

Indexed as

Anti-Inflammatory AgentsBiological ProductsBiomechanical PhenomenaClinical ProtocolsDecision Support TechniquesDrug Administration ScheduleHumansProspective StudiesRecovery of FunctionRemission InductionResearch DesignSpainSpineSpondylarthritisTime FactorsTreatment OutcomeAnti-Inflammatory AgentsBiological ProductsTumor Necrosis Factor-alpha

Identifiers

PMID26289076
PMCPMC4546086
OpenAlexW1821170182

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.