Clinical trial NCT01604629: Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondylarthropathies
Keywords: Spondylarthropathies
Persistent clinical remission with anti-TNF therapy
Standardized protocol for dose reduction anti-TNF therapy
Lead sponsor: Spanish Clinical Pharmacology Society
Sponsor class: OTHER
Collaborators: name: Spanish reumatology Society
First posted: 2012-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year
timeFrame: one year after inclusion
Secondary outcomes:
measure: Proportion of patients in remission one year after inclusion in the study
timeFrame: one year
measure: Proportion of patients who experience a clinical reactivation
timeFrame: last study visit (up to 3 years or December 2014)
measure: Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit
timeFrame: last study visit (up to 3 years or December 2014)
measure: Proportion of patients who are kept in the ideal therapeutic objective in the last follow visit
timeFrame: last study visit (up to 3 years or December 2014)
measure: Time to clinical reactivation
timeFrame: last study visit (up to 3 years or December 2014)
measure: Withdrawal because of clinical requirement to modify the antiTNF treatment.
timeFrame: last study visit (up to 3 years or December 2014)
measure: NSAIDs use
timeFrame: last study visit (up to 3 years or December 2014)
measure: Suspected Serious Adverse Reactions
timeFrame: last study visit (up to 3 years or December 2014)
measure: Time to Suspected Serious Adverse Reaction
timeFrame: last study visit (up to 3 years or December 2014)
measure: Proportion of patients in remission after two years from inclusion in the study
timeFrame: 2 years
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Monte Naranco
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Llerena
country: Spain
facility: Hospital General de Llerena-Zafra
state: Badajoz
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Palamós
country: Spain
facility: Hospital Comarcal de Palamós
state: Girona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Illes Balears
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrín
state: Las Palmas
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Alacant
country: Spain
facility: Hospital Clínic Universitari Sant Joan d'Alacant
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: IMIM-Hospital del Mar
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Tarragona
country: Spain
facility: Hospital Sant Pau i Santa Tecla
city: Valencia
country: Spain
facility: Hospital General de Valencia
Study officials:
affiliation: Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB
name: Gratacós Jordi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.