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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

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

Published in: Trials | Issue 1/2015

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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.

Trial registration

EudraCT 2011-005871-18 (21 December 2011)
Appendix
Available only for authorised users
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Metadata
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
Authors
Caridad Pontes
Jordi Gratacós
Ferran Torres
Cristina Avendaño
Jesús Sanz
Antoni Vallano
Xavier Juanola
Eugenio de Miguel
Raimon Sanmartí
Gonzalo Calvo
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0828-5

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