Overview

A Study Comparing SB4 to EnbrelĀ® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will receive SB4 for an additional 48 weeks.
Phase:
Phase 3
Details
Lead Sponsor:
Samsung Bioepis Co., Ltd.
Treatments:
Etanercept
Methotrexate