Evidence map›Paper›PMID 30010481›Full record

Trial reportmAbs

Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial.

Won Park, Ljubinka Božić-Majstorović, Dragana Milakovic, Alfredo Berrocal Kasay, Elias Chalouhi El-Khouri, Fedra Irazoque-Palazuelos, Francisco Fidencio Cons Molina, Pavel Shesternya, Pedro Miranda, Francisco G Medina-Rodriguez and 17 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 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.

NCT02149121 phase3completednot on this map

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis

TypeinterventionalSponsorCelltrionRan2014 to 2017Enrolled384ConditionsRheumatoid ArthritisArmsCT-P10, Rituxan, MabThera
NCT05716334 completednot on this map

Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator (BRAVO): a CanVasc Multicentre Study

TypeobservationalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2021 to 2025Enrolled201ConditionsANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review
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

27 authors.

Won Parka Medicine/Rheumatology , IN-HA University, School of Medicine , Incheon , Republic of Korea.
Ljubinka Božić-Majstorovićb University Clinical Centre of the Republic of Srpska , Banja Luka , Bosnia and Herzegovina.
Dragana Milakovicb University Clinical Centre of the Republic of Srpska , Banja Luka , Bosnia and Herzegovina.
Alfredo Berrocal Kasayc ABK Reuma SRL - Medicentro Biociencias , Lima , Peru.
Elias Chalouhi El-Khourid Clinica Internacional , Lima , Peru.
Fedra Irazoque-Palazuelose Centro de Investigación y Tratamiento Reumatológico S.C ., Mexico City , Mexico.
Francisco Fidencio Cons Molinaf Centro de Investigación en Artritis y Osteoporosis , Mexicali , Mexico.
Pavel Shesternyag Krasnoyarsk State Medical University , Krasnoyarsk , Russia.
Pedro Mirandah Centro de Estudios Reumatológicos , Santiago , Chile.
Francisco G Medina-Rodriguezi La Salle University , Mexico City , Mexico.
Piotr Wilandj Medical University of Wroclaw , Wroclaw , Poland.
Slawomir Jekak Department of Rheumatology and Connective Tissue Diseases , University Hospital No. 2, Collegium Medicum UMK , Bydgoszcz , Poland.
Jose Chavez-Corralesl Clinica San Borja , Lima , Peru.
Olena Garmishm Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine , Kyiv , Ukraine.
Thomas Linden MVZ für Rheumatologie und Autoimmundiagnostik, Halle (Salle) , Germany.
Dmytro Rekalovo Department of Internal Diseases , Zaporizhzhia State Medical University , Zaporizhzhia , Ukraine.
Pawel Hrycajp Department of Rheumatology and Clinical Immunology , Poznań University of Medical Sciences , Poznań , Poland.
Andreas Krauseq Medical Centre for Rheumatology Berlin-Buch, Immanuel Krankenhaus Berlin , Berlin , Germany.
Natalia Fominar Kemerovo Regional Clinical Hospital , Kemerovo , Russian Federation.
Olena Piuras Department of Rheumatology , Kyiv Regional Clinical Hospital , Kyiv , Ukraine.
Mauricio Abello-Banfit Centro Integral de Reumatologia del Caribe , Barranquilla , Colombia.
Chang-Hee Suhu Department of Rheumatology , Ajou University School of Medicine , Suwon , Republic of Korea.
Seung Cheol Shimv Department of Internal Medicine , Chungnam National University Hospital , Daejeon , Republic of Korea.
Sang Joon Leew CELLTRION, Inc ., Incheon , Republic of Korea.
Sung Young Leew CELLTRION, Inc ., Incheon , Republic of Korea.
Sung Hwan Kimw CELLTRION, Inc ., Incheon , Republic of Korea.
Dae Hyun Yoox Division of Rheumatology , Hanyang University Hospital for Rheumatic Diseases , Seoul , Republic of Korea.ORCID 0000-0002-0643-4008

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced RTX (EU-RTX; MabThera®) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration-time curve (AUC) from time zero to last measurable concentration (AUC

Indexed as

AdultAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsArea Under CurveArthritis, RheumatoidBiosimilar PharmaceuticalsDouble-Blind MethodFemaleHumansInfectionsMaleMiddle AgedRituximabTherapeutic EquivalencyTreatment OutcomeAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsBiosimilar PharmaceuticalsCT-P10RituximabbiosimilarCT-P10equivalencerheumatoid arthritisRituximab

Identifiers

PMID30010481
PMCPMC6152436

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.