Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 we...
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.
Tracking Information
- NCT #
- NCT04227366
- Collaborators
- Not Provided
- Investigators
- Study Chair: Yulia Linkova, MD, PhD JSC BIOCAD
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