Evidence map›Paper›PMID 31607268›Full record

Trial reportBMC pediatrics2019

Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan.

Hitoshi Tajiri, Katsuhiro Arai, Seiichi Kagimoto, Reiko Kunisaki, Nobuyuki Hida, Noriko Sato, Hiroshi Yamada, Mieko Nagano, Yutaka Susuta, Kunihiko Ozaki and 2 more

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

Trial report in BMC pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01585155 (Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 36% 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.

NCT01585155 phase3completednot on this map

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.

TypeinterventionalSponsorTanabe Pharma CorporationRan2012 to 2014Enrolled21ConditionsPediatric Ulcerative ColitisArmsTA-650
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. 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

12 authors at 7 institutions in 1 country.

Hitoshi TajiriDepartment of Pediatrics, Osaka General Medical Center, Osaka, Japan. tajiriji@gh.opho.jp.ORCID 0000-0002-8100-2715
Katsuhiro AraiDivision of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan.
Seiichi KagimotoDivision of General Pediatrics, Saitama Children's Medical Center, Saitama, Japan.
Reiko KunisakiInflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan.
Nobuyuki HidaDivision of Internal Medicine, Department of Inflammatory Bowel Disease, Hyogo College of Medicine, Hyogo, Japan.
Noriko SatoIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Hiroshi YamadaIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Mieko NaganoIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Yutaka SusutaIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Kunihiko OzakiIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Kazuoki KondoIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Mitsubishi Group (Japan) · JPHyogo Medical University · JPKitasato Institute Hospital · JPNational Center For Child Health and Development · JPOsaka Prefectural Medical Center · JPSaitama Children's Medical Center · JPYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPediatric ulcerative colitis (UC) is typically more extensive and has a more active disease course than adult UC, and requires early treatment augmentation to achieve and maintain disease remission. The present study aimed to investigate the efficacy, safety, and pharmacokinetic profile of infliximab (IFX) in pediatric patients with moderate-to-severe UC and inadequate response to existing treatment.

methodsThis open-label, uncontrolled, multicenter, Phase 3 trial was conducted at 17 centers in Japan between April 2012 and September 2014. Pediatric patients (aged 6-17 years) diagnosed with moderate-to-severe UC received a treatment protocol comprising 5 mg/kg IFX at Weeks 0, 2, and 6, and Clinical Activity Index (CAI)-based responders at Week 8 also received treatment at 8-week intervals at Weeks 14 and 22, with a final evaluation at Week 30.

resultsA total of 21 patients were treated in this study. IFX therapy rapidly improved clinical symptoms, and this effect was maintained for up to 30 weeks. Overall CAI-based remission rate was 42.9% and overall Pediatric Ulcerative Colitis Activity Index (PUCAI)-based remission rate was 19.0%. Median partial Mayo score was 6.0 at baseline and 4.0 at Week 30 (overall). Among the eight patients who underwent sigmoidoscopy, Mayo response was achieved at Week 30 (overall) in three patients (37.5%). Trough serum IFX concentrations in Week 8 CAI-based responders were maintained throughout the study period. Adverse events and serious adverse events were observed in 95.2 and 14.3% of patients, respectively.

conclusionsThese results support the use of IFX in the treatment of pediatric patients with UC with inadequate response to existing treatment.

trial registrationClinicalTrials.gov, registration number: NCT01585155 .

Indexed as

AdolescentChildColitis, UlcerativeFemaleGastrointestinal AgentsHumansInfliximabJapanMaleTreatment OutcomeGastrointestinal AgentsInfliximabInfliximabJapanMulticenter trialPediatricPhase 3Ulcerative colitis

Identifiers

PMID31607268
PMCPMC6790239
OpenAlexW2980145790

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.