MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis

Summary

Primary objective of the study is to establish a 3-way PK similarity bridge between MabionCD20 (candidate biosimilar to rituximab), MabThera® (EU-sourced rituximab) and Rituxan® (US-sourced rituximab) following the administration of these drugs to patients with moderate-to-severe rheumatoid arthritis. Main secondary objective is to confirm therapeutic similarity between MabionCD20 and the reference rituximab.

Timeline

Start

2023-08-03

Primary completion

2023-08-03

Completion

2023-08-03

Outcome

Outcome not reported

Stopped (Enrollment): “Study closed for business reasons before patient recruitment was initiated.”

Drugs

Indications