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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
596
Investigational Site
Kielce, Poland
Investigational Site
Southampton, Hampshire, United Kingdom
American College of Rheumatology 20% Response Criteria (ACR20)
Time frame: Week 24
ACR20
Time frame: Week 52
American College of Rheumatology 50% Response Criteria (ACR50)
Time frame: Week 24, Week 52
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