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
Outcome
Met primary endpoint
paper All confidence intervals were contained within the predefined equivalence margins. PMID 38258678 ↗
paper INTERPRETATION: BAT1806/BIIB800 showed equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles as reference tocilizumab. PMID 38258678 ↗
release “results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA ® /RoACTEMRA ® (tocilizumab). The study met its primary endpoints” biogen.com ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT1806 | Unknown | 8 mg/kg | Intravenous |
| Comparator | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |