GO-DACT方案：一项多中心、随机、双盲、平行组研究，比较戈利木单抗联合甲氨蝶呤（MTX）与MTX单药治疗的疗效。

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.

作者信息

Vieira-Sousa Elsa, Canhão Helena, Alves Pedro, Rodrigues Ana Maria, Teixeira Filipa, Tavares-Costa José, Bernardo Alexandra, Pimenta Sofia, Pimentel-Santos Fernando, Gomes João L, Aguiar Renata, Videira Taciana, Pinto Patrícia, Catita Cristina, Santos Helena, Borges Joana, Sequeira Graça, Ribeiro Célia, Teixeira Lídia, Ávila-Ribeiro Pedro, Martins Fernando M, Ribeiro Ruy M, Fonseca João Eurico

机构信息

Hospital 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, Portugal.

NOVA Medical School|Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisboa, Portugal.

出版信息

Acta Reumatol Port. 2018 Apr-Jun;43(2):80-92.

PMID:30091952

Abstract

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.

摘要

GO-DACT是一项由研究者发起的全国性多中心随机安慰剂对照双盲试验，该试验将指（趾）炎作为主要终点进行评估。对甲氨蝶呤和生物性改善病情抗风湿药物初治、至少有一处活动性指（趾）炎的银屑病关节炎患者，被分配接受戈利木单抗联合甲氨蝶呤或安慰剂联合甲氨蝶呤治疗，为期24周。将临床指标（指（趾）炎严重程度评分和利兹指（趾）炎指数）以及影像学指标（高分辨率磁共振成像）等作为疗效评估指标。GO-DACT的主要目标是提供证据以改进活动性指（趾）炎银屑病关节炎患者的治疗方案和护理。在本手稿中，我们描述了GO-DACT方案以及该试验方法的一般概念。