A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients

Summary

The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.

Timeline

Start

2015-06-10

Primary completion

2018-01-18

Completion

2018-01-18

Publications

• Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
• Genovese MC, Glover J, Greenwald M, Porawska W, El Khouri EC, Dokoupilova E, Vargas JI, Stanislavchuk M, Kellner H, Baranova E, Matsunaga N, Alten R. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther. 2019 Dec 12;21(1):281. doi: 10.1186/s13075-019-2046-0.

Drugs

Indications