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 (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Gratacós, Jordi (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Torres, Ferran (Hospital Clínic i Provincial de Barcelona)
Avendaño Sola, Cristina (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Sanz, Jesús (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Vallano, Antoni (Hospital Universitari de Bellvitge)
Juanola, Xavier (Hospital Universitari de Bellvitge)
de Miguel, Eugenio (Hospital Universitario La Paz (Madrid))
Sanmartí, Raimon
Calvo, Gonzalo (Hospital Clínic i Provincial de Barcelona)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2015
Resum:	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.
Nota:	Altres ajuts: MSSSI/EC11-229
Drets:	Aquest 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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Spondyloarthritis/therapy ; DMARDs (biologic) ; Disease Activity ; Treatment
Publicat a:	Trials, Vol. 16 (august 2015) , ISSN 1745-6215

DOI: 10.1186/s13063-015-0828-5
PMID: 26289076

12 p, 694.3 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d’Investigació i Innovació Parc Taulí (I3PT)
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