NCT04227366

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	BCD-089	BCD-089 162 mg SC
BIOLOGICAL	Placebo	Placebo
DRUG	Methotrexat	15 to 25 mg/week

Timeline

• Start date: 2019-11-19
• Primary completion: 2021-03-15
• Completion: 2022-03-01
• First posted: 2020-01-13
• Last updated: 2022-05-12

Locations

1 site across 1 country: Russia