The purpose of this study is to evaluate the safety and effectiveness of combination therapy with etanercept and narrow-band (NB) UVB phototherapy for the treatment of psoriasis in a pilot study. This is a Phase 4 clinical study being conducted under an Amgen Investigational New Drug Application (IND).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Three times a week (TIW) for 12 weeks
50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12
Time frame: 3 months
Time to PASI 75 responses
Time frame: Variable
Proportion of subjects achieving PASI 90 at Week 12
Time frame: 3 months
Improvement in PASI at Week 12
Time frame: 3 months
Improvement in body surface area (BSA) involved with psoriasis at Week 12
Time frame: 3 months
Improvement in physician global assesssment of psoriasis, including an assessment of the proportion of subjects achieving clear or almost clear status at Week 12
Time frame: 3 months
Improvement in patient global assesssment of psoriasis at Week 12
Time frame: 3 months
Improvement in Dermatology Life Quality Index (DLQI) at Week 12
Time frame: 3 months
Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12
Time frame: 3 months
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