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

Rheumatoid Arthritis Clinical Trial

Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Status Completed

Clinical Trial 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.

Clinical Trial Description

BCD-089-3/SOLAR is the international, multicenter, double blind, placebo-controlled phase III clinical study.

The main period of the study (Weeks 0-24) is blinded; study subjects will receive BCD-089/placebo.

At Week 24 the study will become open-label and all patients will receive BCD-089 once a week for 4 weeks. At week 28 patients who achieved the RA remission at week 24 will be switched to BCD-089 Q2W dosing regimen and will receive it through Week 51. Patients who failed to achieve remission at week 24 will receive BCD-089 once a week through Week 51. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT04227366
• Study type: Interventional
• Source: Biocad
• Status: Completed
• Phase: Phase 3
• Start date: November 19, 2019
• Completion date: March 1, 2022