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
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.


CONCLUSIONS
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.


BACKGROUND
EudraCT 2011-005871-18 (21 December 2011).
Clinical Pharmacology Unit, Hospital de Sabadell. Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, Sabadell (Barcelona), Spain. cpontes@tauli.cat.
Caridad
C
Pontes
Rheumatology Service, Hospital de Sabadell. Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, 08208, Sabadell (Barcelona), Spain. jgratacosmas@gmail.com.
Jordi
J
Gratacós
Biostatistics and Data Management Platform, IDIBAPS, Hospital Clínic, Biostatistics Unit. Faculty of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain. ferran.torres@uab.es.
Ferran
F
Torres
Clinical Pharmacology Service. Hospital Puerta de Hierro-Majadahonda, Madrid, Spain. cavendano@salud.madrid.org.
Cristina
C
Avendaño
Rheumatology Service, Hospital Puerta de Hierro-Majadahonda, Madrid, Spain. jesussanzsanz4@gmail.com.
Jesús
J
Sanz
Clinical Pharmacology Service, Hospital Universitario de Bellvitge - IDIBELL- Universitat de Barcelona, Bellvitge (Barcelona), Spain. avallano@bellvitgehospital.cat.
Antoni
A
Vallano
Rheumatology Service, Hospital Universitario de Bellvitge - IDIBELL- Universitat de Barcelona, Bellvitge (Barcelona), Spain. x.juanola@bellvitgehospital.cat.
Xavier
X
Juanola
Rheumatology Service, Hospital Universitario La Paz, Madrid, Spain. eugenio.demiguel@gmail.com.
Eugenio
E
de Miguel
Rheumatology Service, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain. SANMARTI@clinic.ub.es.
Raimon
R
Sanmartí
Clinical Pharmacology Service, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain. gcalvo@clinic.ub.es.
Gonzalo
G
Calvo
D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001688:Biological Products / Q000008:administration & dosage* / Q000009:adverse effects; D001696:Biomechanical Phenomena; D002985:Clinical Protocols; D003661:Decision Support Techniques; D004334:Drug Administration Schedule; D006801:Humans; D011446:Prospective Studies; D020127:Recovery of Function; D012074:Remission Induction; D012107:Research Design; D013030:Spain; D013131:Spine / Q000187:drug effects* / Q000276:immunology / Q000503:physiopathology; D025241:Spondylarthritis / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000276:immunology
D000893:Anti-Inflammatory Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha