Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study

• Published in: Arthritis research & therapy Vol. 23; no. 1; pp. 51 - 12
• Main Authors: Kay, Jonathan, Jaworski, Janusz, Wojciechowski, Rafal, Wiland, Piotr, Dudek, Anna, Krogulec, Marek, Jeka, Slawomir, Zielinska, Agnieszka, Trefler, Jakub, Bartnicka-Maslowska, Katarzyna, Krajewska-Wlodarczyk, Magdalena, Klimiuk, Piotr A., Lee, Sang Joon, Bae, Yun Ju, Yang, Go Eun, Yoo, Jae Kyoung, Furst, Daniel E., Keystone, Edward
• Format: Journal Article
• Language: English
• Published: England BioMed Central 05.02.2021; BMC
• Subjects: Adalimumab; Arthritis; Biological products; Biologics; Biosimilars; Comparative effectiveness; Dictionaries; Drug dosages; FDA approval; Immunogenicity; Immunotherapy; Monoclonal antibodies; Population; Rheumatoid arthritis; Sample size; TNF inhibitors; Tuberculosis; Tumor necrosis factor-TNF; Usability; Poland; Bulgaria; United States > US; Biosimilars; Comparative effectiveness; Immunogenicity; Tumor necrosis factor inhibitors; Biologics; Rheumatoid arthritis; Monoclonal antibodies; Safety; Adalimumab

To demonstrate equivalent efficacy of the proposed high-concentration (100 mg/ml), citrate-free adalimumab biosimilar CT-P17 to European Union-approved adalimumab (EU-adalimumab) in subjects with active rheumatoid arthritis (RA). This randomized, double-blind phase III study ( ClinicalTrials.gov , N...