MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

Summary

The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis. Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.

Timeline

Start

2020-08-03

Primary completion

2021-08-31

Completion

2022-06-06

Publications

• Zubrzycka-Sienkiewicz A, Klama K, Ullmann M, Petit-Frere C, Baker P, Monnet J, Illes A. Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study. RMD Open. 2024 Feb 5;10(1):e003596. doi: 10.1136/rmdopen-2023-003596.

Drugs

Indications