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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4
Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
Have a current diagnosis of active tuberculosis
Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
Have any of the following conditions
Primary purpose
Allocation
Interventional model
Masking
596 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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