Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF
REDES-TNF
Evaluation of Clinical Value of Standardized Protocol for Dose-reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy: Open-label, Controlled, Randomized, Multicenter Trial.
2 other identifiers
interventional
120
1 country
31
Brief Summary
The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2012
Typical duration for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 17, 2015
November 1, 2015
2.8 years
May 17, 2012
November 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Society of Reumatology (SER) consensus (BASDAI \< 4, global clinical impression by physician \<4 and by patient \< 4 and axial nocturnal pain \<4) after one year
one year after inclusion
Secondary Outcomes (10)
Proportion of patients in remission one year after inclusion in the study
one year
Proportion of patients who experience a clinical reactivation
last study visit (up to 3 years or December 2014)
Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit
last study visit (up to 3 years or December 2014)
Proportion of patients who are kept in the ideal therapeutic objective in the last follow visit
last study visit (up to 3 years or December 2014)
Time to clinical reactivation
last study visit (up to 3 years or December 2014)
- +5 more secondary outcomes
Study Arms (2)
Reduced doses of anti-TNF
EXPERIMENTALStandardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab
Stable doses of anti-TNF
ACTIVE COMPARATORStable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis
Interventions
Standardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab
Stable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis
Eligibility Criteria
You may qualify if:
- Patients older than 18 years
- Patients with Spondylarthropathies according ASAS group criteria.
- Patients under treatment with anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab) who present established clinical remission
- Patients to give their informed consent to participate in the study
You may not qualify if:
- Patients with secondary Spondylarthropathies
- Patients with Spondylarthropathies and predominantly clinical of peripheral arthritis which receive anti-TNF therapy by peripheral symp tons.
- Patients with Spondylarthropathies and other associated diseases that hinders or modify the clinical evaluation of the patient (fibromyalgia, chronic inflammatory disorders…)
- Patients with bowel inflammatory disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Clinical Pharmacology Societylead
- Spanish reumatology Societycollaborator
Study Sites (31)
Hospital Clínic Universitari Sant Joan d'Alacant
Alicante, Alacant, Spain
Hospital General de Llerena-Zafra
Llerena, Badajoz, Spain
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
IMIM-Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Hospital Reina Sofía
Córdoba, Córdoba, Spain
Hospital Comarcal de Palamós
Palamós, Girona, Spain
Hospital Universitario de Guadalajara
Guadalajara, Guadalajara, Spain
Hospital Juan Canalejo
A Coruña, La Coruña, 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
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
Hospital Monte Naranco
Oviedo, Principality of Asturias, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Clínico de Salamanca
Salamanca, Salamanca, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Sant Pau i Santa Tecla
Tarragona, Tarragona, Spain
Hospital General de Valencia
Valencia, Valencia, Spain
Related Publications (1)
Gratacos J, Pontes C, Juanola X, Sanz J, Torres F, Avendano C, Vallano A, Calvo G, de Miguel E, Sanmarti R; REDES-TNF investigators. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019 Jan 8;21(1):11. doi: 10.1186/s13075-018-1772-z.
PMID: 30621746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gratacós Jordi, MD, PhD
Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study coordinator
Study Record Dates
First Submitted
May 17, 2012
First Posted
May 24, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2015
Study Completion
September 1, 2015
Last Updated
November 17, 2015
Record last verified: 2015-11