Evidence map›Paper›PMID 28720139›Full record

Trial reportBMC musculoskeletal disorders2017

The GOLMePsA study protocol: an investigator-initiated, double-blind, parallel-group, randomised, controlled trial of GOLimumab and methotrexate versus methotrexate in early diagnosed psoriatic arthritis using clinical and whole body MRI outcomes.

Gabriele De Marco, Philip Helliwell, Dennis McGonagle, Paul Emery, Laura C Coates, Elizabeth M A Hensor, Helena Marzo-Ortega

Open access · goldAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Choosing the right treatment for patients with psoriatic arthritis.Therapeutic advances in musculoskeletal disease · 2020
    Review
  6. Article
  7. Review
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

7 authors at 1 institution in 1 country.

Gabriele De MarcoNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
Philip HelliwellNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
Dennis McGonagleNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
Paul EmeryNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
Laura C CoatesNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
Elizabeth M A HensorNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
Helena Marzo-OrtegaLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, 2nd Floor Chapeltown Road, Leeds, West Yorkshire, LS7 4SA, UK. medhmo@leeds.ac.uk.ORCID http://orcid.org/0000-0002-9683-3407
University of Leeds · GB

Funding

Department of Health RC-PG-0407-10054Versus Arthritis 18475Versus Arthritis 20639
6 · The paper itself

Abstract

backgroundPsoriatic arthritis (PsA) is a chronic inflammatory arthritis which impacts significantly on the quality of life and work capacity of affected individuals. Recent evidence has shown that early control of inflammation in PsA leads to improved long-term outcomes. It is postulated that prompt intervention after diagnosis using a remission-induction treatment strategy will lead to improved outcomes and optimal disease control of PsA. The aim of the present study was to compare the clinical efficacy of a treatment strategy in newly diagnosed, treatment naïve PsA subjects, using the combination of golimumab (GOL), methotrexate (MTX) and steroids versus standard care (MTX monotherapy plus steroids). METHODS/

designGOLMePsA is an investigator initiated, phase IIIb, single-centre, randomised, double-blind, placebo-controlled, two-armed, parallel-group, imaging-supplemented study. Eighty-eight PsA patients, diagnosed within 24 months prior to screening and treatment naïve, will be randomised at baseline to receive: (arm 1) the combination of intramuscular/intra-articular prednisolone, MTX and GOL or (arm 2) the combination of intramuscular/intra-articular prednisolone, MTX and placebo for 24 weeks (interventional period). Primary outcome measure is clinical improvement (at least 1 unit difference) in the Psoriatic ArthritiS Disease Activity Score (PASDAS) composite index. Reflecting a "step down" therapeutic approach, all participants successfully completing the interventional period will be followed up for a further 28 weeks. During this observational period, stable maintenance MTX monotherapy will continue for both arms, unless in case of intolerance or PsA relapse. In the latter case, additional treatment will be provided. Overall, the GOLMePsA study length is planned to be 52 weeks. DISCUSSION: The hypothesis underlining this study is that very early treatment with first-line GOL reduces disease activity in PsA, in comparison to conventional therapy.

trial registrationEudraCT 2013-004122-28 . 24/09/2013.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodDrug Therapy, CombinationHumansMagnetic Resonance ImagingMethotrexateTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsgolimumabMethotrexateEarly diagnosisMinimal disease activityPsoriatic arthritisTime-to-recurrenceTNF-inhibitorTreatment-näiveTreat-to-target

Identifiers

PMID28720139
PMCPMC5516354
OpenAlexW2737036730

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.