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, in improving dactylitis and enthesitis, in MTX-naive psoriatic arthritis patients

被引：0

作者：

Vieira-Sousa, E. ^{[1
,2
]}

Canhao, H. ^{[3
]}

Alves, P. ^{[4
]}

Rodrigues, A. M. ^{[5
,6
]}

Teixeira, F. ^{[7
]}

Tavares-Costa, J. ^{[7
]}

Bernardo, A. ^{[8
]}

Pimenta, S. ^{[8
]}

Pimentel-Santos, F. ^{[9
]}

Gomes, J. L. ^{[9
]}

Aguiar, R. ^{[10
]}

Videira, T. ^{[11
]}

Pinto, P. ^{[11
]}

Catita, C.

Santos, H. ^{[12
]}

Borges, J. ^{[13
]}

Sequeira, G. ^{[13
]}

Ribeiro, C. ^{[13
]}

Teixeira, L. ^{[14
]}

Avila-Ribeiro, P. ^{[1
,2
]}

Martins, F. M. ^{[15
]}

Ribeiro, R. M. ^{[16
]}

Fonseca, J. E. ^{[1
,2
]}

机构：

[1] Univ Lisbon, Ctr Acad Med Lisboa, Serv Reumatol & Doengas osseas Metab, Hosp Santa Maria,CHLN,Fac Med, Lisbon, Portugal

[2] Univ Lisbon, Ctr Acad Med Lisboa, Unidade Invest Reumatol, Fac Med,Inst Med Mol, Lisbon, Portugal

[3] Univ Nova Lisboa, Fac Ciencias Med, NOVA Med Sch, Chron Dis Res Ctr CEDOC, Lisbon, Portugal

[4] Ctr Hosp Lisboa Cent, Serv Radiol, Lisbon, Portugal

[5] Univ Lisbon, Unidade Reumatol, Hosp Santo Espirito Ilha Terceira, Acores, Lisbon, Portugal

[6] Univ Lisbon, Fac Med, Lisbon, Portugal

[7] Unidade Local Saude Alto Minho, Serv Reumatol & Doencas Osseas Metab, Ponte do Lima, Portugal

[8] Ctr Hosp Sao Joao do Porto, Serv Reumatol & Doencas Osseas Metab, Porto, Portugal

[9] Hosp Egas Moniz, CHLO, Serv Reumatol & Doencas Osseas Metab, Lisbon, Portugal

[10] Ctr Hosp Baixo Vouga, Serv Reumatol, Aveiro, Portugal

[11] Ctr Hosp Vila Nova de Caia, Serv Reumatol, Vila Nova De Caia, Portugal

[12] Hosp Particular Algarve, Faro, Portugal

[13] Ctr Hosp Algarve, Unidade Faro, Faro, Portugal

[14] Hosp Garcia Orta, Serv Reumatol, Almada, Portugal

[15] Soc Portuguesa Reumatol, Lisbon, Portugal

[16] Univ Lisbon, Fac Med, Lab Biomatemat, Lisbon, Portugal

来源：

ACTA REUMATOLOGICA PORTUGUESA | 2018年 / 43卷 / 02期

关键词：

Clinical trial; Dactylitis; Treatment algorithm; Psoriatic arthritis; PLACEBO-CONTROLLED TRIAL; DISEASES CANDIDATES; RECOMMENDATIONS; UPDATE; THERAPY; VALIDATION; MANAGEMENT; SEVERITY; PSAMRIS; INDEX;

D O I：

暂无

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The GO-DACT is an investigator-initiated, multicentric randomized placebo-controlled double-blinded trial, that assesses dactylitis as primary endpoint. Psoriatic arthritis patients naive 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, tor 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.

引用

页码：80 / 92

页数：13

共 45 条

[1] THE GO-DACT PROTOCOL: A RANDOMIZED CONTROLLED TRIAL TO COMPARE THE EFFICACY OF GOLIMUMAB IN COMBINATION WITH METHOTREXATE (MTX) VERSUS MTX MONOTHERAPY, IN IMPROVING DACTYLITIS AND ENTHESITIS, IN MTX NAIVE PSORIATIC ARTHRITIS PATIENTS
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