Evidence map›Paper›PMID 32193187›Full record

Trial reportAnnals of the rheumatic diseases2020

GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis.

Elsa Vieira-Sousa, Pedro Alves, Ana M Rodrigues, Filipa Teixeira, Jose Tavares-Costa, Alexandra Bernardo, Sofia Pimenta, Fernando M Pimentel-Santos, João Lagoas Gomes, Renata Aguiar and 14 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02065713 (A Multicentre, Randomized, Double-blind, Parallel-group Study To Compare The Efficacy Of Golimumab In Combination With Methotrexate), which is not on this map. Cited by 29 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 10 pooled it
7.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02065713 phase3completednot on this map

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.

TypeinterventionalSponsorInstituto de Medicina Molecular João Lobo AntunesRan2014 to 2017Enrolled44ConditionsPsoriatic ArthritisArmsGolimumab, Methotrexate, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 10 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Guideline
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  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Infections in psoriatic arthritis: association with treatment.Therapeutic advances in musculoskeletal disease · 2024
    Review
  19. Article
  20. Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 13 institutions in 2 countries.

Elsa Vieira-SousaRheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal elsa-sousa@hotmail.com.ORCID 0000-0002-7170-8802
Pedro AlvesRadiology Department, Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal.
Ana M RodriguesRheumatology Unit, Hospital de Santo Espirito da Ilha Terceira EPER, Angra do Heroismo, Ilha Terceira, Portugal.
Filipa TeixeiraRheumatology Department, Unidade Local de Saúde do Alto Minho EPE, Ponte de Lima, Portugal.
Jose Tavares-CostaRheumatology Department, Unidade Local de Saúde do Alto Minho EPE, Ponte de Lima, Portugal.
Alexandra BernardoRheumatology Department, Centro Hospitalar Universitário de São João, Porto, Portugal.
Sofia PimentaRheumatology Department, Centro Hospitalar Universitário de São João, Porto, Portugal.
Fernando M Pimentel-SantosRheumatology Department, Hospital de Egas Moniz, Lisboa, Portugal.
João Lagoas GomesRheumatology Department, Hospital de Egas Moniz, Lisboa, Portugal.
Renata AguiarRheumatology Department, Hospital Infante Dom Pedro, Aveiro, Portugal.
Patrícia PintoRheumatology Department, Hospital Centre of Vila Nova de Gaia Espinho, Vila Nova de Gaia, Porto, Portugal.
Taciana VideiraRheumatology Department, Hospital Centre of Vila Nova de Gaia Espinho, Vila Nova de Gaia, Porto, Portugal.
Cristina CatitaRheumatology Clinic, Hospital Particular do Algarve, Faro, Portugal.
Helena SantosRheumatology Department, Instituto Português de Reumatologia, Lisboa, Portugal.
Joana BorgesRheumatology Department, Instituto Português de Reumatologia, Lisboa, Portugal.
Graça SequeiraRheumatology Department, Centro Hospitalar Universitário do Algarve EPE, Faro, Portugal.
Célia RibeiroRheumatology Department, Centro Hospitalar Universitário do Algarve EPE, Faro, Portugal.
Lídia TeixeiraRheumatology Department, Hospital Garcia de Orta EPE, Almada, Portugal.
Pedro Ávila-RibeiroRheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Fernando M MartinsPortuguese Society of Rheumatology, Lisboa, Portugal.
Helena CanhãoComprehensive Health Research Center (CHRC), Lisbon, Portugal.
Iain B McInnesInstitute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
Ruy M RibeiroLaboratório de Biomatemática, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
João Eurico FonsecaRheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
University of Lisbon · PTAlgarve Biomedical Center · PTAdministração Regional de Saúde de Lisboa e Vale do Tejo · PTCentro Hospitalar de Vila Nova de Gaia · PTHospital de Egas Moniz · PTHospital de São João · PTInstituto Português de Malacologia · PTHospital de Santo Espirito de Angra do Heroísmo · PTHospital Garcia de Orta · PTSociedade Portuguesa de Cardiologia · PTUnidade Local de Saúde de São José · PTUniversidade Nova de Lisboa · PTUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis.

methodsMulticentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint.

resultsTwenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.

conclusionsThe combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis. TRIAL REGISTRATION NUMBER: NCT02065713.

Indexed as

AdultAgedAntibodies, MonoclonalAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodDrug Therapy, CombinationFemaleFoot JointsHand JointsHumansMagnetic Resonance ImagingMaleMethotrexateMiddle AgedTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsgolimumabMethotrexateTumor Necrosis Factor Inhibitorsanti-TNFmethotrexateoutcomes researchpsoriatic arthritis

Identifiers

PMID32193187
PMCPMC7147178
OpenAlexW3010828189

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.