Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
50 mg once weekly
Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)
Time frame: 24 weeks
Etanercept seroreactivity response to etanercept (manufactured using the SFP)
Time frame: week 12
neutralizing antibodies to etanercept
Time frame: week 12 and 24
Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments
Time frame: week 24
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