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

Background: dose 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/Design: to address this issue th...

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Autores: Pontes García, Caridad, Gratacós Masmitjà, Jordi, Torres, Ferran, Avendaño, Cristina, Sanz, Jesús, Vallano Ferraz, Antonio, Juanola, Xavier, Miguel, Eugenio de, Sanmartí Sala, Raimon, Calvo Rojas, Gonzalo
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2015
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/67495
Acceso en línea:https://hdl.handle.net/2445/67495
Access Level:acceso abierto
Palabra clave:Malalties de les articulacions
Reumatisme
Espondiloartritis anquilosant
Administració de medicaments
Protocols clínics
Assaigs clínics
Joints diseases
Rheumatism
Ankylosing spondylitis
Administration of drugs
Medical protocols
Clinical trials
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spelling 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 trialPontes García, CaridadGratacós Masmitjà, JordiTorres, FerranAvendaño, CristinaSanz, JesúsVallano Ferraz, AntonioJuanola, XavierMiguel, Eugenio deSanmartí Sala, RaimonCalvo Rojas, GonzaloMalalties de les articulacionsReumatismeEspondiloartritis anquilosantAdministració de medicamentsProtocols clínicsAssaigs clínicsJoints diseasesRheumatismAnkylosing spondylitisAdministration of drugsMedical protocolsClinical trialsBackground: dose 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/Design: to 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.BioMed Central2015201520152015info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion12 p.application/pdfhttps://hdl.handle.net/2445/67495Articles publicats en revistes (Patologia i Terapèutica Experimental)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: http://dx.doi.org/10.1186/s13063-015-0828-5Trials, 2015, vol. 16, p. 370http://dx.doi.org/10.1186/s13063-015-0828-5cc-by (c) Pontes García, Caridad et al., 2015http://creativecommons.org/licenses/by/3.0/esinfo:eu-repo/semantics/openAccessoai:recercat.cat:2445/674952026-05-29T05:05:01Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Pontes García, Caridad
Malalties de les articulacions
Reumatisme
Espondiloartritis anquilosant
Administració de medicaments
Protocols clínics
Assaigs clínics
Joints diseases
Rheumatism
Ankylosing spondylitis
Administration of drugs
Medical protocols
Clinical trials
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Pontes García, Caridad
Gratacós Masmitjà, Jordi
Torres, Ferran
Avendaño, Cristina
Sanz, Jesús
Vallano Ferraz, Antonio
Juanola, Xavier
Miguel, Eugenio de
Sanmartí Sala, Raimon
Calvo Rojas, Gonzalo
author Pontes García, Caridad
author_facet Pontes García, Caridad
Gratacós Masmitjà, Jordi
Torres, Ferran
Avendaño, Cristina
Sanz, Jesús
Vallano Ferraz, Antonio
Juanola, Xavier
Miguel, Eugenio de
Sanmartí Sala, Raimon
Calvo Rojas, Gonzalo
author_role author
author2 Gratacós Masmitjà, Jordi
Torres, Ferran
Avendaño, Cristina
Sanz, Jesús
Vallano Ferraz, Antonio
Juanola, Xavier
Miguel, Eugenio de
Sanmartí Sala, Raimon
Calvo Rojas, Gonzalo
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Malalties de les articulacions
Reumatisme
Espondiloartritis anquilosant
Administració de medicaments
Protocols clínics
Assaigs clínics
Joints diseases
Rheumatism
Ankylosing spondylitis
Administration of drugs
Medical protocols
Clinical trials
topic Malalties de les articulacions
Reumatisme
Espondiloartritis anquilosant
Administració de medicaments
Protocols clínics
Assaigs clínics
Joints diseases
Rheumatism
Ankylosing spondylitis
Administration of drugs
Medical protocols
Clinical trials
description Background: dose 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/Design: to 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.
publishDate 2015
dc.date.none.fl_str_mv 2015
2015
2015
2015
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/67495
url https://hdl.handle.net/2445/67495
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: http://dx.doi.org/10.1186/s13063-015-0828-5
Trials, 2015, vol. 16, p. 370
http://dx.doi.org/10.1186/s13063-015-0828-5
dc.rights.none.fl_str_mv cc-by (c) Pontes García, Caridad et al., 2015
http://creativecommons.org/licenses/by/3.0/es
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Pontes García, Caridad et al., 2015
http://creativecommons.org/licenses/by/3.0/es
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 12 p.
application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv Articles publicats en revistes (Patologia i Terapèutica Experimental)
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812455

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