The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy
The GO-DACT is an investigator-initiated, national, multicentric randomized placebo-controlled double-blinded trial, that assesses dactylitis as primary endpoint. Psoriatic arthritis patients naïve to methotrexate and biologic disease modifying anti-rheumatic drugs, with at least one active dactylit...
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Sociedade Portuguesa de Reumatologia
2018-04-01
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doaj-8783b20802c246cab2152e5862e2f99c2020-11-24T20:43:51ZengSociedade Portuguesa de ReumatologiaActa Reumatológica Portuguesa0303-464X2018-04-01201828092AO180088The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapyElsa Vieira-Sousa0Helena Canhão1Pedro Alves2Ana Maria Rodrigues3Filipa Teixeira4José Tavares-Costa5Alexandra Bernardo6Sofia Pimenta7Fernando Pimentel-Santos8João L Gomes9Renata Aguiar10Taciana Videira11Patrícia Pinto12Cristina CatitaHelena SantosJoana BorgesGraça Sequeira13Célia Ribeiro14Lídia Teixeira15Pedro Ávila-Ribeiro16Fernando M MartinsRuy M RibeiroJoão Eurico Fonseca17Hospital de Santa Maria, CHLN; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Centro Académico de Medicina de Lisboa, Lisboa, PortugalNOVA Medical School|Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisboa, PortugalCentro Hospitalar de Lisboa Central, Lisboa, PortugalHospital do Santo Espírito da Ilha Terceira, Açores e Faculdade de Medicina da Universidade de Lisboa, Lisboa, PortugalUnidade Local de Saúde do Alto Minho, Ponte de Lima, PortugalUnidade Local de Saúde do Alto Minho, Ponte de Lima, PortugalCentro Hospitalar São João do Porto, Porto, PortugalCentro Hospitalar São João do Porto, Porto, PortugalCentro Hospitalar de Lisboa Ocidental (CHLO), Hospital de Egas Moniz, Lisboa, PortugalCentro Hospitalar de Lisboa Ocidental (CHLO), Hospital de Egas Moniz, Lisboa, PortugalCentro Hospitalar do Baixo Vouga, Aveiro, PortugalCentro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, PortugalCentro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, PortugalCentro Hospitalar do Algarve, Faro, PortugalCentro Hospitalar do Algarve, Faro, PortugalHospital Garcia de Orta, Almada, PortugalHospital de Santa Maria, CHLN; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Centro Académico de Medicina de Lisboa, Lisboa, PortugalHospital de Santa Maria, CHLN; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Centro Académico de Medicina de Lisboa, Lisboa, PortugalThe GO-DACT is an investigator-initiated, national, multicentric randomized placebo-controlled double-blinded trial, that assesses dactylitis as primary endpoint. Psoriatic arthritis patients naïve to methotrexate and biologic disease modifying anti-rheumatic drugs, with at least one active dactylitis, were assigned to golimumab in combination with methotrexate or placebo in combination with methotrexate, for 24 weeks. Both clinical (dactylitis severity score and the Leeds dactylitis index) and imaging (high resolution magnetic resonance imaging), among others, were assessed as outcomes. The main objective of GO-DACT is to provide evidence to improve the treatment algorithm and care of psoriatic arthritis patients with active dactylitis. In this manuscript we describe the GO-DACT protocol and general concepts of the methodology of this trial.http://www.actareumatologica.com/files/article/1214_the_go_dact_protocol_a_multicentre_randomized_double_blind_parallel_group_study_to_compare_the_efficacy_of_golimumab_in_combination_with_methotrexate_mtx_versus_mtx_monotherapy_file.pdfclinical trialtreatment algorithmpsoriatic arthritisdactylitis |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Elsa Vieira-Sousa Helena Canhão Pedro Alves Ana Maria Rodrigues Filipa Teixeira José Tavares-Costa Alexandra Bernardo Sofia Pimenta Fernando Pimentel-Santos João L Gomes Renata Aguiar Taciana Videira Patrícia Pinto Cristina Catita Helena Santos Joana Borges Graça Sequeira Célia Ribeiro Lídia Teixeira Pedro Ávila-Ribeiro Fernando M Martins Ruy M Ribeiro João Eurico Fonseca |
spellingShingle |
Elsa Vieira-Sousa Helena Canhão Pedro Alves Ana Maria Rodrigues Filipa Teixeira José Tavares-Costa Alexandra Bernardo Sofia Pimenta Fernando Pimentel-Santos João L Gomes Renata Aguiar Taciana Videira Patrícia Pinto Cristina Catita Helena Santos Joana Borges Graça Sequeira Célia Ribeiro Lídia Teixeira Pedro Ávila-Ribeiro Fernando M Martins Ruy M Ribeiro João Eurico Fonseca The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy Acta Reumatológica Portuguesa clinical trial treatment algorithm psoriatic arthritis dactylitis |
author_facet |
Elsa Vieira-Sousa Helena Canhão Pedro Alves Ana Maria Rodrigues Filipa Teixeira José Tavares-Costa Alexandra Bernardo Sofia Pimenta Fernando Pimentel-Santos João L Gomes Renata Aguiar Taciana Videira Patrícia Pinto Cristina Catita Helena Santos Joana Borges Graça Sequeira Célia Ribeiro Lídia Teixeira Pedro Ávila-Ribeiro Fernando M Martins Ruy M Ribeiro João Eurico Fonseca |
author_sort |
Elsa Vieira-Sousa |
title |
The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy |
title_short |
The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy |
title_full |
The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy |
title_fullStr |
The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy |
title_full_unstemmed |
The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy |
title_sort |
go-dact protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (mtx) versus mtx monotherapy |
publisher |
Sociedade Portuguesa de Reumatologia |
series |
Acta Reumatológica Portuguesa |
issn |
0303-464X |
publishDate |
2018-04-01 |
description |
The GO-DACT is an investigator-initiated, national, multicentric randomized placebo-controlled double-blinded trial, that assesses dactylitis as primary endpoint. Psoriatic arthritis patients naïve to methotrexate and biologic disease modifying anti-rheumatic drugs, with at least one active dactylitis, were assigned to golimumab in combination with methotrexate or placebo in combination with methotrexate, for 24 weeks. Both clinical (dactylitis severity score and the Leeds dactylitis index) and imaging (high resolution magnetic resonance imaging), among others, were assessed as outcomes. The main objective of GO-DACT is to provide evidence to improve the treatment algorithm and care of psoriatic arthritis patients with active dactylitis. In this manuscript we describe the GO-DACT protocol and general concepts of the methodology of this trial. |
topic |
clinical trial treatment algorithm psoriatic arthritis dactylitis |
url |
http://www.actareumatologica.com/files/article/1214_the_go_dact_protocol_a_multicentre_randomized_double_blind_parallel_group_study_to_compare_the_efficacy_of_golimumab_in_combination_with_methotrexate_mtx_versus_mtx_monotherapy_file.pdf |
work_keys_str_mv |
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