Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

Summary

This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA). The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.

Timeline

Start

2023-03-30

Primary completion

2024-03-04

Completion

2024-09-24

Publications

• Luque M, Zhelyazkova K, Vashishta L, Rai M, Sattar A, Petrovic K, Bucknall R, Leutz S, Berti F. Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study. BioDrugs. 2026 Jan;40(1):135-149. doi: 10.1007/s40259-025-00748-8. Epub 2025 Nov 3.

Drugs

Indications