3상완료

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

연구 개요

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.

스폰서
리드: 삼성바이오에피스
적응증
Rheumatoid Arthritis
중재
Enbrel (etanercept), SB4 (proposed biosimilar to etanercept)
목표 등록
596
시작일
2013-06-01
완료(예정)
2015-10-01

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