drugset / Trial / NCT02683564
BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.
Timeline
- Start
- 2016-02
- Primary completion
- 2017-07
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BOW015 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Comparator | Infliximab | Monoclonal antibody | 3 mg/kg | Intravenous |