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

• Main Authors: 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
• Format: Article
• Language: English
• Published: Sociedade Portuguesa de Reumatologia 2018-04-01
• Series: Acta Reumatológica Portuguesa
• Subjects: clinical trial; treatment algorithm; psoriatic arthritis; dactylitis
• Online Access: 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

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.