The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.
This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study
Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).
Time frame: Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24
Time frame: Week 24
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12
Time frame: Week 12
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24
Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.
Time frame: Week 24
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12
Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.
Time frame: Week 12
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