Evidence map›Paper›PMID 26223543›Full record

Trial reportArthritis care & research2015

A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis-Related Arthritis.

Rubén Burgos-Vargas, Shirley M L Tse, Gerd Horneff, Aileen L Pangan, Jasmina Kalabic, Sandra Goss, Kristina Unnebrink, Jaclyn K Anderson

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 care & research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01166282 (A Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis), which is not on this map. Cited by 50 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 7 pooled it
7.2field-weighted citation impact, top 3% 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.

NCT01166282 phase3completednot on this map

A Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2010 to 2015Enrolled46ConditionsEnthesitis Related Arthritis (ERA)Armsadalimumab, placebo for adalimumab
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 7 syntheses or guidelines pooled it, 108 citations in OpenAlex.

  1. Tumor necrosis factor (TNF) inhibitors for juvenile idiopathic arthritis.The Cochrane database of systematic reviews · 2025
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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

8 authors at 5 institutions in 4 countries.

Rubén Burgos-VargasHospital General de Mexico, Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
Shirley M L TseThe Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Gerd HorneffAsklepios Klinik Sankt Augustin, Sankt Augustin, Germany.
Aileen L PanganAbbVie, North Chicago, Illinois.
Jasmina KalabicAbbVie Deutschland, Ludwigshafen, Germany.
Sandra GossAbbVie, North Chicago, Illinois.
Kristina UnnebrinkAbbVie Deutschland, Ludwigshafen, Germany.
Jaclyn K AndersonAbbVie, North Chicago, Illinois.
AbbVie (United States) · USLudwigshafen University of Business and Society · DEAsklepios Klinik Sankt Augustin · DEHospital General de México · MXSickKids Foundation · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEnthesitis-related arthritis (ERA) is a juvenile idiopathic arthritis (JIA) category, primarily affecting entheses and peripheral joints. This study evaluated efficacy, safety, and pharmacokinetics of adalimumab versus placebo in patients with ERA.

methodsThis is a phase III, multicenter, randomized double-blind study in patients ages ≥6 to <18 years with ERA treated with adalimumab (24 mg/m(2) , maximum dose 40 mg every other week) or placebo for 12 weeks, followed by up to 192 weeks of open-label adalimumab. The primary end point was percent change from baseline in number of active joints with arthritis (AJC) at week 12. Samples were collected to determine adalimumab serum concentrations. Adverse events (AEs) were assessed throughout the study.

resultsForty-six patients were randomized (31 adalimumab/15 placebo). At baseline, mean age was 12.9 years, mean duration of ERA symptoms was 2.6 years, mean AJC was 7.8, and mean enthesitis count was 8.1. Mean percent change from baseline in AJC at week 12 was greater in the adalimumab group versus placebo (-62.6% versus -11.6%; P = 0.039). Most secondary variables favored adalimumab versus placebo at week 12. Treatment response further increased with continued adalimumab therapy through week 52. Mean steady-state adalimumab serum concentrations were 7.5-11.8 μg/ml, similar to patients age ≥2 years with polyarticular JIA. AE rates were similar between placebo and adalimumab: any AE (53.3% versus 67.7%), serious AEs (0% versus 3.2%), and infectious AEs (20.0% versus 29.0%).

conclusionAdalimumab reduced signs and symptoms of ERA at week 12, with improvement sustained through week 52. The safety profile was consistent with previous adalimumab studies.

Indexed as

AdalimumabAdolescentAntirheumatic AgentsArthritis, JuvenileChildDouble-Blind MethodFemaleHumansMaleTreatment OutcomeAdalimumabAntirheumatic Agents

Identifiers

PMID26223543
PMCPMC5057351
OpenAlexW2138181327

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.