Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Summary

This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group, active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared with RoActemra in subjects with RA that is inadequately controlled by MTX. The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.

Timeline

Start

2018-12-19

Primary completion

2021-01-05

Completion

2021-01-05

Publications

• Ebbers HC, Taylor PC, Leng X, Wei W, Kinsella NM, Zhou Y, Yang X, Chamberlain P. A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product. Rheumatol Ther. 2025 Jun;12(3):529-546. doi: 10.1007/s40744-025-00760-y. Epub 2025 Apr 8.
• Leng X, Leszczynski P, Jeka S, Liu S, Liu H, Miakisz M, Gu J, Kilasonia L, Stanislavchuk M, Yang X, Zhou Y, Dong Q, Mitroiu M, Addison J, Rezk MF, Zeng X. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48). Arthritis Res Ther. 2024 Sep 7;26(1):157. doi: 10.1186/s13075-024-03375-w.
• Leng X, Leszczynski P, Jeka S, Liu SY, Liu H, Miakisz M, Gu J, Kilasonia L, Stanislavchuk M, Yang X, Zhou Y, Dong Q, Rezk M, Mitroiu M, Addison J, Zeng X. Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. 2024 Jan;6(1):e40-e50. doi: 10.1016/S2665-9913(23)00237-0.

Drugs

Indications