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FRI0137 (2018) : Efficacy, safety and immunogenicity from week 30 to week 54 in a randomised, double-blind phase iii study comparing a proposed infliximab biosimilar (PF-06438179/GP1111 with reference infliximab

Researchers

Presenter

  • R. Alten

Principal Investigators

  • V. Tseluyko

  • T. Hala

  • S. Mehmedagic

  • M. Pileckyte

  • E. Dokoupilová

  • D. Jovic

  • M. Rehman

  • M. Zhang

  • L. Sewell

  • S. Hackley

  • S. Salts

  • C. Cronenberger

  • K. Schumacher

  • O. von Richter

  • B. Batko

Medical Centers

  • Schlosspark Clinic, Berlin, Germany

  • Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine

  • Center for Clinical and Basic Research, Pardubice, Czech Republic

  • Clinical Center University of Sarajevo, Sarajevo, Bosnia And Herzegowina

  • Lithuanian University of Health Sciences, Kaunas, Lithuania

  • Medical Plus s.r.o., Uherske Hradiste, University of Veterinary and Pharmaceutical Sciences, Brno, Czech Republic

  • University Clinical Center of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina

  • Pfizer Inc, Andover, MA

  • Pfizer Oncology, La Jolla, CA

  • Pfizer Inc., Cambridge, MA

  • Pfizer Ltd, Sandwhich, UK

  • Pfizer Inc, Collegeville, PA

  • Sandoz Biopharmaceuticals, Holzkirchen, Germany

  • J. Dietl Specialist Hospital, Krakow, Poland

Locations

  • Germany

  • Ukraine

  • Czech Republic

  • Bosnia and Herzegovina

  • Lithuania

  • United States

  • United Kingdom

  • Poland

Companies

  • PharmAbcine Inc.

Study Components

Therapeutic Area

  • N/A

Disease

  • N/A

Biomarkers

  • Telomerase reverse transcriptase

  • Albumin/creatinine

Drug/Treatment

  • Infliximab Biosimilar

  • Methotrexate

  • Infliximab

Outcome

  • N/A

Study Design

  • Randomized

  • Double Blind/Blinded

  • Dose Escalation

  • Parallel Group

Phase

  • III

Study Id's

  • N/A

Sponsors

  • Pfizer Inc

Result

  • N/A

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