A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis

Summary

This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis

Timeline

Start

2018-11-26

Primary completion

2019-10-08

Completion

2020-04-24

Outcome

Met primary endpoint

paper The 95% CI (- 5.94 to 5.94) and 90% CI (- 4.98 to 4.98) were within predefined equivalence margins for both assumptions and equivalent efficacy was concluded. PMID 33546755 ↗

release “A phase III randomised, double-blind study demonstrated the equivalence efficacy to CT-P17 at week 24 to reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis.” celltrion.com ↗

release “CT-P17 met the primary objective of demonstrating equivalent efficacy” celltrion.com ↗

Publications

• Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Kim SH, Bae YJ, Yang GE, Yoo JK, Kay J, Keystone E. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology (Oxford). 2022 Apr 11;61(4):1385-1395. doi: 10.1093/rheumatology/keab460.
• Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021 Feb 5;23(1):51. doi: 10.1186/s13075-020-02394-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	CT-P17	Monoclonal antibody	40 mg	Subcutaneous

Indications