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POS0287 (2022) : A PHASE III, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED CLINICAL TRIAL TO COMPARE BAT1806/BIIB800, A PROPOSED TOCILIZUMAB BIOSIMILAR, WITH TOCILIZUMAB REFERENCE PRODUCT IN SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE THERAPY

Researchers

Presenter

  • X. Leng

Principal Investigators

  • P. Leszczynski

  • S. Jeka

  • S. Liu

  • H. Liu

  • M. Miakisz

  • J. Gu

  • L. Kilasonia

  • M. Stanislavchuk

  • X. Yang

  • Y. Zhou

  • Q. Dong

  • M. Mitroiu

  • J. Addison

  • X. Zeng

Medical Centers

  • Peking Union Medical College Hospital, Rheumatology and Clinical Immunology, Beijing, China

  • Poznan University of Medical Sciences, Department of Pathophysiology, Poznan, Poland

  • Clinic and Department of Rheumatology and Connective Tissue Diseases University Hospital No 2 in Bydgoszcz Collegium Medicum UMK in Toruń, Department of Rheumatology and Connective Tissue Diseases, Toruń, Poland

  • Qilu Hospital, Shandong University, Department of Hematology, Jinan, China

  • Twoja Przychodnia Medyczne Centrum, Internal Medicine and Rheumatology, Nowa Sol, Poland

  • The Sixth Affiliated Hospital of Sun Yat-sen University, Department of Gastroenterology, Guangzhou, China

  • Tbilisi Heart and vascular Clinic Ltd, Rheumatology, Tbilisi, Georgia

  • National Pirogov Memorial Medical University, Vinnytsya, Ukraine, Vinnytsya, Ukraine

  • Biothera Solutions Ltd., Medical Affairs, Guangzhou, China

  • Bio-Thera Solutions, Ltd., Research and Development, Guangzhou, China

  • Biogen International GmbH, Evidence Generation Biosimilars, Baar, Switzerland

  • Biogen Idec Ltd., Clinical Research, Maidenhead, United Kingdom

  • Peking Union Medical College Hospital, Department of Gastroenterology, Beijing, China

Locations

  • China

  • Poland

  • Georgia

  • Ukraine

  • Switzerland

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • Autoimmune (AI)

Disease

  • Rheumatoid arthritis

Biomarkers

  • Cancer antigen 15-3

  • Collagen type IV alpha 2 chain

Drug/Treatment

  • Methotrexate

  • Tocilizumab

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Double Blind/Blinded

  • Controlled

Phase

  • III

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A

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