Evidence map›Paper›PMID 26139307›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2015

A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis.

J Sieper, D van der Heijde, M Dougados, W P Maksymowych, B B Scott, J A Boice, Y Berd, G Bergman, S Curtis, A Tzontcheva and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01453725 (A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis), which is not on this map. Cited by 108 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 10 pooled it
19.8field-weighted citation impact, top 1% 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.

NCT01453725 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Protocol No. P07642, Also Known as MK-8259-006-02).

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2012 to 2015Enrolled198ConditionsSpondylitis, AnkylosingArmsGolimumab, Placebo
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 10 syntheses or guidelines pooled it, 222 citations in OpenAlex.

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  2. La Tunisie medicale · 2025
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48 more citing papers are in PubMed but not listed here.

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

12 authors at 4 institutions in 5 countries.

J SieperUniversity Clinic Benjamin Franklin, Berlin, Germany.
D van der HeijdeLeiden University Medical Centre, Leiden, The Netherlands, University Hospital Maastricht, Maastricht, The Netherlands, and Diakonhjemmet Hospital, Oslo, Norway.
M DougadosParis-Descartes University, Hôpital Cochin, AP-HP, INSERM U1153, and PRES Sorbonne Paris-Cité, Paris, France.
W P MaksymowychUniversity of Alberta, Edmonton, Alberta, Canada.
B B ScottMerck & Company, Inc., Kenilworth, New Jersey.
J A BoiceMerck & Company, Inc., Kenilworth, New Jersey.
Y BerdMerck & Company, Inc., Kenilworth, New Jersey.
G BergmanMerck & Company, Inc., Kenilworth, New Jersey.
S CurtisMerck & Company, Inc., Kenilworth, New Jersey.
A TzontchevaMerck & Company, Inc., Kenilworth, New Jersey.
S HuyckMerck & Company, Inc., Kenilworth, New Jersey.
H H WengMerck & Company, Inc., Kenilworth, New Jersey.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USDélégation Paris 5 · FRLeiden University · NLUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAxial spondyloarthritis (SpA) is a chronic inflammatory disease characterized by back pain and stiffness. The objective of this study was to determine whether golimumab is superior to placebo in patients with nonradiographic axial SpA.

methodsThis phase III, double-blind, randomized, placebo-controlled trial was performed to evaluate subcutaneous golimumab (50 mg) versus placebo in patients ages ≥18 years to ≤45 years who had active nonradiographic axial SpA according to the Assessment of SpondyloArthritis international Society (ASAS) criteria for ≤5 years since diagnosis, high disease activity, and an inadequate response to or intolerance of nonsteroidal antiinflammatory drugs. Patients were randomized 1:1 to receive golimumab or placebo subcutaneously every 4 weeks. The primary end point was 20% improvement according to the ASAS criteria (ASAS20) at week 16. Key secondary end points were an ASAS40 response, ASAS partial remission, 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and change in the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) index for sacroiliac (SI) joint inflammation (SPARCC score).

resultsOf the 198 patients randomized, 197 were treated (97 received golimumab, and 100 received placebo). The mean age of the patients was 31 years, and 57.1% were male. At baseline, the mean ± SD BASDAI was 6.5 ± 1.5, the mean ± SD ASDAS was 3.5 ± 0.9, and the mean ± SD SPARCC score was 11.3 ± 14.0. The primary end point, an ASAS20 response, was achieved by significantly more patients in the golimumab group compared with the placebo group (71.1% versus 40.0%; P < 0.0001). An ASAS40 response was also achieved by significantly more patients in the golimumab group compared with the placebo group (56.7% versus 23.0%; P < 0.0001). The incidence of adverse events did not differ meaningfully between groups.

conclusionPatients with active nonradiographic axial SpA treated with golimumab had significantly greater improvement in symptoms compared with patients treated with placebo. Golimumab was well tolerated and had a favorable risk/benefit profile.

Indexed as

Axis, Cervical VertebraSeverity of Illness IndexAdultAntibodies, MonoclonalAntirheumatic AgentsDouble-Blind MethodEndpoint DeterminationFemaleHumansInjections, SubcutaneousInternational CooperationLongitudinal StudiesMaleRisk AssessmentSpondylarthritisTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsgolimumabTumor Necrosis Factor-alpha

Identifiers

PMID26139307
PMCPMC4755041
OpenAlexW1770652604

What OpenQuestion holds

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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.