A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Update Il y a 4 ans
Reference: EUCTR2012-005026-30

Woman and Man

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Extract

The primary objective of this study is to demonstrate the equivalence of SB4 to Enbrel® at Week 24, in terms of American College of Rheumatology 20% response criteria (ACR 20) response rate in subjects with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.


Inclusion criteria

  • Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO