Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF

NCT ID: NCT01604629

Last Updated: 2015-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-09-30

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.

Detailed Description

It 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.

Conditions

Spondylarthropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reduced doses of anti-TNF

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

Group Type: EXPERIMENTAL

Reduced doses of anti-TNF

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Stable doses of anti-TNF

Intervention Type: DRUG

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

Interventions

Reduced doses of anti-TNF

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

Intervention Type: DRUG

Stable doses of anti-TNF

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

Intervention Type: DRUG

Other Intervention Names

Adalimumab: 40 mg / 3 weeks; Etanercept: 50 mg / 10 days; Golimumab: 50 mg / 6 weeks; Infliximab: 3 mg/kg / 8 weeks; Adalimumab: 40 mg / 2 weeks; Etanercept: 25 mg / 3 days ó 50 mg /7 days; Golimumab: 50 mg / 4 weeks; Infliximab: 5 mg/kg / 6-8 weeks

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Patients under chronic therapy with anti-TNF therapy who received the patterns of reduction that will be explored in the experimental group, or low doses or most spaced that those in the experimental group before study inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish reumatology Society

UNKNOWN

Sponsor Role: collaborator

Spanish Clinical Pharmacology Society

OTHER

Sponsor Role: lead

Responsible Party

Dra. Caridad Pontes

Study coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gratacós Jordi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB

Locations

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, Spain

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

IMIM-Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Universitario de Bellvitge

L'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 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, 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

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 30621746 (View on PubMed)

Other Identifiers

2011-005871-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REDES-TNF/2012

Identifier Type: -

Identifier Source: org_study_id