Evidence map›Paper›PMID 28507219›Full record

Trial reportAnnals of the rheumatic diseases2018

Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial.

Hermine I Brunner, Nicolino Ruperto, Nikolay Tzaribachev, Gerd Horneff, Vyacheslav G Chasnyk, Violeta Panaviene, Carlos Abud-Mendoza, Andreas Reiff, Ekaterina Alexeeva, Nadina Rubio-Pérez and 23 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01230827 (A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis), which is not on this map. Cited by 61 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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.

NCT01230827 phase3terminatednot on this map

A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard Therapy

TypeinterventionalSponsorJanssen Research & Development, LLCRan2010 to 2014Enrolled173ConditionsJuvenile Idiopathic ArthritisArmsCNTO 148 (Golimumab), Placebo, Methotrexate
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. Tumor necrosis factor (TNF) inhibitors for juvenile idiopathic arthritis.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Guideline
  8. Guideline
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Review
  18. Review
  19. Review
  20. Review

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors.

Hermine I BrunnerCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Nicolino RupertoIstituto Giannina Gaslini, Pediatria II - Rheumatologia, PRINTO, Genoa, Italy.
Nikolay TzaribachevPediatric Rheumatology Research Institute, Bad Bramstedt, Germany.
Gerd HorneffDepartment of Pediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.
Vyacheslav G ChasnykHospital Pediatry, State Pediatric Medical Academy, Saint Petersburg, Russian Federation.
Violeta PanavieneCentre of Pediatrics, Vilnius University, Vilnius, Lithuania.
Carlos Abud-MendozaRegional Unit of Rheumatology and Osteoporosis, Central Hospital "Dr. Ignacio Morones Prieto" and Faculty of Medicine, Universidad Autónoma de San Luis Potosí, Mexico, San Luis Potosí, Mexico.
Andreas ReiffDepartment of Rheumatology, Children's Hospital of Los Angeles, Los Angeles, California, USA.
Ekaterina AlexeevaChildren's Health of RAMS and IM Sechenov First Moscow State Medical University, Moscow, Russian Federation.
Nadina Rubio-PérezHospital Universitario, Universidad Autónoma de Nuevo León, Nuevo León, Mexico.
Vladimir KeltsevSamara Regional Clinical Hospital, Samara, Russian Federation.
Daniel J KingsburyRandall Children's Hospital at Legacy Emanuel, Portland, Oregon, USA.
Maria Del Rocio Maldonado VelázquezHospital Infantil de Mexico Federico Gomez, Distrito Federal, Mexico.
Irina NikishinaPediatric Department, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russian Federation.
Earl D SilvermanDepartment of Rheumatology, The Hospital for Sick Children, Toronto, Canada.
Rik JoosZNA Jan Palfijn, Antwerpen, Belgium.
Elzbieta SmolewskaMedical University of Łódź, Łódź, Poland.
Márcia BandeiraHospital Pequeno Principe, Curitiba, Brazil.
Kirsten MindenDepartment of Pediatric Rheumatology, Charité University Medicine, Berlin, Germany.
Annet van Royen-KerkhofDepartment of Paediatric Immunology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
Wolfgang EmmingerUniversity Children's Hospital, Wien, Austria.
Ivan FoeldvariKlinikum Eilbek, Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany.
Bernard R LauwerysPôle de pathologies rhumatismales systémiques et inflammatoires, Université catholique de Louvain, Institut de Recherche Clinique, Brussels, Belgium.
Flavio SztajnbokNucleo de Estudos da Saúde do Adolescente, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil.
Keith E GilmerJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Zhenhua XuJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Jocelyn H LeuJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Lilianne KimJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Sarah L LamberthJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Matthew J LozaJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Daniel J LovellCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Alberto MartiniIstituto Giannina Gaslini, Pediatria II - Rheumatologia, PRINTO, Genoa, Italy.
Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA).

methodsIn this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m

resultsAmong 173 patients with polyJIA enrolled, 89.0% (154/173) had a JIA ACR30 response and 79.2%/65.9%/36.4% demonstrated JIA ACR50/70/90 responses in Part 1. At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates (golimumab vs placebo: 32/78=41% vs 36/76=47%; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=12.8% vs 9/76=11.8%). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with <1% of all injections. PK analysis confirmed adequate golimumab dosing for polyJIA.

conclusionAlthough the primary endpoint was not met, golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA. Golimumab was well tolerated, and no unexpected safety events occurred. CLINICAL

trial registrationNCT01230827; Results.

Indexed as

AdolescentAntibodies, MonoclonalAntirheumatic AgentsArthritisArthritis, JuvenileChildChild, PreschoolDouble-Blind MethodDrug Therapy, CombinationFemaleHumansInjections, SubcutaneousMaleMethotrexateRemission InductionSymptom Flare UpAntibodies, MonoclonalAntirheumatic AgentsgolimumabMethotrexateanti-tumour necrosis factorbiologicsgolimumabjuvenile idiopathic arthritis

Identifiers

PMID28507219
PMCPMC5754736

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.