drugset / Trial / NCT02744196

Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis

NCT02744196 ↗

Phase 3 Completed 159 enrolled Biocad
RandomizedParallel-groupTriple-blindTreatment

Summary

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.

Timeline

Start
2015-01
Primary completion
2017-02
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Acellbia Monoclonal antibody 600 mg Intravenous
Background Methotrexate Small molecule — —

Indications