A multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy, in improving dactylitis and enthesitis, in MTX-naïve psoriatic arthritis patients

Autor: Elsa Vieira de-Sousa, Helena Canhão, Alves, P., Ana Maria Rodrigues, Teixeira, F., Tavares-Costa, J., Bernardo, A., Pimenta, S., Pimentel-Santos, F., Gomes, J. L., Aguiar, R., Videira, T., Pinto, P., Catita, C., Helena Santos, Sequeira, G., Ribeiro, C., Teixeira, L., Ávila-Ribeiro, P., Martins, F. M., Ribeiro, R. M., Fonseca, J. E.
Přispěvatelé: NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM), Centro de Estudos de Doenças Crónicas (CEDOC)
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Universidade Nova de Lisboa
Popis: The GO-DACT is an investigator-initiated, 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 psoria - tic arthritis patients with active dactylitis. In this manuscript we describe the GO-DACT protocol and general concepts of the methodology of this trial. publishersversion published
Databáze: OpenAIRE