A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

Summary

This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.

Timeline

Start

2022-09-14

Primary completion

2023-06-29

Completion

2023-11-23

Outcome

Met primary endpoint

release “Therapeutic equivalence of CT-P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52.” celltrion.com ↗

Publications

• Burmester G, Trefler J, Racewicz A, Jaworski J, Zielinska A, Krogulec M, Jeka S, Wojciechowski R, Kolossa K, Dudek A, Krajewska-Wlodarczyk M, Hrycaj P, Klimiuk PA, Kim S, Suh J, Yang G, Kim Y, Jung Y, Park G, Smolen JS. Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis. Clin Drug Investig. 2025 Aug;45(8):551-563. doi: 10.1007/s40261-025-01453-8. Epub 2025 Jul 12.

Drugs

Indications