drugset / Trial / NCT04227366

Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

NCT04227366 ↗

Phase 3 Completed 154 enrolled Biocad
RandomizedParallel-groupDouble-blindTreatment

Summary

BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor. The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate.

Timeline

Start
2019-11-19
Primary completion
2021-03-15
Completion
2022-03-01

Publications

  • Background Mazurov V.I., Korolev M.A., Prystrom A.M., Kunder E.V., Soroka N.F., Kastanayan A.A., Povarova T.V., Plaksina T.V., Antipova O.V., Kretchikova D.G., Smakotina S.A., Tciupa O.A., Puntus E.V., Raskina T.A., Shilova L.N., Kropotina T.V., Nesmeyanova O.B., Popova T.A., Vinogradova I.B., Linkova Yu.N., Dokukina E.A., Plotnikova A.V., Pukhtinskaia P.S., Zinkina-Orikhan A.V., Eremeeva A.V., Lutckii A.A. Effectiveness and safety of levilimab in combination with methotrexate in treatment of patients with active rheumatoid arthritis resistant to methotrexate monotherapy (double-blinded randomized placebo controlled phase III clinical study SOLAR). Modern Rheumatology Journal. 2021;15(4):13-23. https://doi.org/10.14412/1996-7012-2021-4-13-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Levilimab Monoclonal antibody 162 mg Subcutaneous
Background Methotrexat Unknown 15 mg —
Background Methotrexat Unknown 25 mg —

Indications