drugset / Trial / NCT06475508

Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis

NCT06475508

Phase 3 Completed 465 enrolled AO GENERIUM
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate® and Actemra® in the treatment of patients with rheumatoid arthritis with moderate to high disease activity. Participants received an intravenous dose of tocilizumab 8 mg/kg once 4 weeks. The time on study treatment was 24 weeks.

Timeline

Start
2023-02-13
Primary completion
2024-01-05
Completion
2024-06-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Complarate® Unknown 8 mg/kg Intravenous
Comparator Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications