Evidence mapPaperPMID 39351819Full record

Trial reportClinical and translational science2024

Pharmacokinetic comparison of subcutaneously administered CT-P13 (biosimilar of infliximab) via autoinjector and pre-filled syringe in healthy participants.

Ye Chan Park, Jae Hoon Kim, Sung Hyun Kim, Ju Hyun Lee, Jang Hee Hong, Jin-Gyu Jung, Jung Sunwoo

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
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.

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

1 citing paper in PubMed.

  1. Trial
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.

Ye Chan ParkClinical Trials Center, Chungnam National University Hospital, Daejeon, Korea.ORCID 0009-0007-2762-7742
Jae Hoon KimClinical Trials Center, Chungnam National University Hospital, Daejeon, Korea.ORCID 0000-0001-5643-0913
Sung Hyun KimMedical Science Division, Celltrion, Inc., Incheon, Korea.
Ju Hyun LeeMedical Science Division, Celltrion, Inc., Incheon, Korea.ORCID 0009-0008-4152-8545
Jang Hee HongClinical Trials Center, Chungnam National University Hospital, Daejeon, Korea.ORCID 0000-0002-0623-5455
Jin-Gyu JungDepartment of Family Medicine, Chungnam National University Hospital, Daejeon, Korea.ORCID 0000-0002-2591-4867
Jung SunwooClinical Trials Center, Chungnam National University Hospital, Daejeon, Korea.ORCID 0000-0001-8801-0323

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CT-P13, a biosimilar of infliximab, is used to treat inflammatory diseases that arise from immune system complications, resulting in excessive and persistent inflammation. The subcutaneous (SC) formulation of CT-P13 overcomes the drawback of prolonged administration associated with the intravenous (IV) infliximab biosimilar, necessitating autoinjector (AI) administration. This randomized, open-label, two-arm, parallel-group, single-dose clinical pharmacology study aimed to evaluate the pharmacokinetics (PK) and safety of CT-P13 SC administration via AI compared with the existing pre-filled syringe (PFS) method. A total of 147 healthy participants were randomized into two groups, of which 139 completed the study. Blood samples were collected from before CT-P13 SC administration to 2016 h after the start of the administration. Serum concentrations were analyzed using the Meso Scale Discovery electrochemiluminescence method. Geometric mean ratios (90% confidence interval) of the AUC

Indexed as

Biosimilar PharmaceuticalsHealthy VolunteersInfliximabSyringesAdultAntibodies, MonoclonalArea Under CurveFemaleHumansInjections, SubcutaneousMaleMiddle AgedTherapeutic EquivalencyYoung AdultAntibodies, MonoclonalBiosimilar PharmaceuticalsCT-P13Infliximab

Identifiers

PMID39351819
PMCPMC11443321

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.