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
Entity
UAM. Departamento de FarmacologíaPublisher
BioMed CentralDate
2015-08-20Citation
10.1186/s13063-015-0828-5
Trials 16.1 (2015): 370
ISSN
1745-6215DOI
10.1186/s13063-015-0828-5Funded by
This research project is fully funded by the Spanish Ministry of Health within the program “Ayudas para el fomento de la investigación clínica independiente del Ministerio de Salud, Política Social e Igualdad - Orden SPI/ 2885/2011, de 20 de octubre”, grant number EC11/229 and Sponsored by the Spanish Society of Clinical Pharmacology (Sociedad Española de Farmacología Clínica - SEFC) and the Spanish Society of Rheumatology (Sociedad Española de Reumatología - SER).Project
Gobierno de España. EC11/229Editor's Version
http://dx.doi.org/10.1186/s13063-015-0828-5Subjects
Disease Activity; Spondyloarthritis/therapy; DMARDs (biologic); Treatment; MedicinaRights
© 2015 Pontes et al.Abstract
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
Files in this item
Google Scholar:Pontes, Caridad
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Gratacós, Jordi
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Torres, Ferrán
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Avendaño Solá, Cristina
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Sanz, Jesús
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Vallano, Antoni
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Juanola, Xavier
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Miguel, Eugenio de
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Sanmartí, Raimon
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Calvo, Gonzalo
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