Status: Planned First registered on: 22/01/2013
Last updated on: 04/04/2013
1. Study identification
EU PAS Register NumberEUPAS3393
Official titleEvaluation of a Standardized Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy
Study title acronymREDES-TNF/2012
Study typeClinical trial; EUDRACT number: 2011-005871-18
Brief description of the studyIt has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameCorporació Sanitaria Parc Tauli - Reumatology Service
Centre locationSabadell, Spain
Details of (Primary) lead investigator
Title Dr
Last name Gratacós
First name Jordi
Is this study being carried out with the collaboration of a research network?
Yes
GRESSER-SEFC (REDES)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?31

Hospital Clinic Barcelona
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hospital Monte Naranco, Oviedo, Asturias, Spain
Hospital General de Llerena-Zafra, Llerena, Badajoz, Spain
Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain
Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, Spain
Hospital Comarcal de Palamós, Palamós, Girona, Spain
Hospital Son Llàtzer, Palma de Mallorca, Illes Balears, Spain
Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/01/2012
Start date of data collection02/07/201202/07/2012
Start date of data analysis19/12/2014
Date of interim report, if expected
Date of final study report30/09/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyInstituto de Salud Carlos III100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Pontes
First name Caridad
Address line 1Parc Taulí, 1
Address line 2 
Address line 3 
CitySabadell 
Postcode08208 
CountrySpain
Phone number (incl. country code)34937231010 
Alternative phone number 
Fax number (incl. country code) 
Email address cpontes@tauli.cat
Public Enquiries
Title Dr 
Last name Gratacós 
First name Jordi 
Address line 1Parc Taulí, 1 
Address line 2 
Address line 3 
CitySabadell 
Postcode08208 
CountrySpain 
Phone number (incl. country code)34937231010 
Alternative phone number 
Fax number (incl. country code) 
Email address jgratacosmas@gmail.com 
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