Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF)

Pontes García, Caridad|||0000-0002-3274-6048; Gratacós, Jordi|||0000-0003-4007-4103; Torres, Ferran|||0000-0002-7355-7913; Avendaño Sola, Cristina|||0000-0001-5437-7215; Sanz, Jesús; Vallano, Antoni|||0000-0002-3648-3492; Juanola, Xavier|||0000-0001-5998-6300; de Miguel, Eugenio|||0000-0001-5146-1964; Sanmartí, Raimon|||0000-0002-8864-3806; Calvo Rojas, Gonzalo|||0000-0001-8860-6653

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF)

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. To address this issue the Spanish Society of Rheumat...

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Autores:	Pontes García, Caridad\|\|\|0000-0002-3274-6048, Gratacós, Jordi\|\|\|0000-0003-4007-4103, Torres, Ferran\|\|\|0000-0002-7355-7913, Avendaño Sola, Cristina\|\|\|0000-0001-5437-7215, Sanz, Jesús, Vallano, Antoni\|\|\|0000-0002-3648-3492, Juanola, Xavier\|\|\|0000-0001-5998-6300, de Miguel, Eugenio\|\|\|0000-0001-5146-1964, Sanmartí, Raimon\|\|\|0000-0002-8864-3806, Calvo Rojas, Gonzalo\|\|\|0000-0001-8860-6653
Tipo de recurso:	artículo
Fecha de publicación:	2015
País:	España
Institución:	Universitat Autònoma de Barcelona
Repositorio:	Dipòsit Digital de Documents de la UAB
Idioma:	inglés
OAI Identifier:	oai:ddd.uab.cat:185402
Acceso en línea:	https://ddd.uab.cat/record/185402 https://dx.doi.org/urn:doi:10.1186/s13063-015-0828-5
Access Level:	acceso abierto
Palabra clave:	Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment

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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, Caridad\|\|\|0000-0002-3274-6048Gratacós, Jordi\|\|\|0000-0003-4007-4103Torres, Ferran\|\|\|0000-0002-7355-7913Avendaño Sola, Cristina\|\|\|0000-0001-5437-7215Sanz, JesúsVallano, Antoni\|\|\|0000-0002-3648-3492Juanola, Xavier\|\|\|0000-0001-5998-6300de Miguel, Eugenio\|\|\|0000-0001-5146-1964Sanmartí, Raimon\|\|\|0000-0002-8864-3806Calvo Rojas, Gonzalo\|\|\|0000-0001-8860-6653Spondyloarthritis/therapyDMARDs (biologic)Disease ActivityTreatmentDose 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. 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. 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. EudraCT (21 December 2011) The online version of this article (doi:10.1186/s13063-015-0828-5) contains supplementary material, which is available to authorized users.Universitat Autònoma de Barcelona. Departament de Medicina 22015-01-0120152015-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/185402https://dx.doi.org/urn:doi:10.1186/s13063-015-0828-5reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:1854022026-06-06T12:50:31Z
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)
spellingShingle	Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) Pontes García, Caridad\|\|\|0000-0002-3274-6048 Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment
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)
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)
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)
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)
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)
dc.creator.none.fl_str_mv	Pontes García, Caridad\|\|\|0000-0002-3274-6048 Gratacós, Jordi\|\|\|0000-0003-4007-4103 Torres, Ferran\|\|\|0000-0002-7355-7913 Avendaño Sola, Cristina\|\|\|0000-0001-5437-7215 Sanz, Jesús Vallano, Antoni\|\|\|0000-0002-3648-3492 Juanola, Xavier\|\|\|0000-0001-5998-6300 de Miguel, Eugenio\|\|\|0000-0001-5146-1964 Sanmartí, Raimon\|\|\|0000-0002-8864-3806 Calvo Rojas, Gonzalo\|\|\|0000-0001-8860-6653
author	Pontes García, Caridad\|\|\|0000-0002-3274-6048
author_facet	Pontes García, Caridad\|\|\|0000-0002-3274-6048 Gratacós, Jordi\|\|\|0000-0003-4007-4103 Torres, Ferran\|\|\|0000-0002-7355-7913 Avendaño Sola, Cristina\|\|\|0000-0001-5437-7215 Sanz, Jesús Vallano, Antoni\|\|\|0000-0002-3648-3492 Juanola, Xavier\|\|\|0000-0001-5998-6300 de Miguel, Eugenio\|\|\|0000-0001-5146-1964 Sanmartí, Raimon\|\|\|0000-0002-8864-3806 Calvo Rojas, Gonzalo\|\|\|0000-0001-8860-6653
author_role	author
author2	Gratacós, Jordi\|\|\|0000-0003-4007-4103 Torres, Ferran\|\|\|0000-0002-7355-7913 Avendaño Sola, Cristina\|\|\|0000-0001-5437-7215 Sanz, Jesús Vallano, Antoni\|\|\|0000-0002-3648-3492 Juanola, Xavier\|\|\|0000-0001-5998-6300 de Miguel, Eugenio\|\|\|0000-0001-5146-1964 Sanmartí, Raimon\|\|\|0000-0002-8864-3806 Calvo Rojas, Gonzalo\|\|\|0000-0001-8860-6653
author2_role	author author author author author author author author author
dc.contributor.none.fl_str_mv	Universitat Autònoma de Barcelona. Departament de Medicina
dc.subject.none.fl_str_mv	Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment
topic	Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment
description	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. 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. 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. EudraCT (21 December 2011) The online version of this article (doi:10.1186/s13063-015-0828-5) contains supplementary material, which is available to authorized users.
publishDate	2015
dc.date.none.fl_str_mv	2 2015-01-01 2015 2015-01-01
dc.type.none.fl_str_mv	Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	https://ddd.uab.cat/record/185402 https://dx.doi.org/urn:doi:10.1186/s13063-015-0828-5
url	https://ddd.uab.cat/record/185402 https://dx.doi.org/urn:doi:10.1186/s13063-015-0828-5
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/
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dc.source.none.fl_str_mv	reponame:Dipòsit Digital de Documents de la UAB instname:Universitat Autònoma de Barcelona
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Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF)

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