Study Complete
Sponsor ID
20040171
Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis
Study Details
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).
Protocol Summary
Primary Outcome Measures
Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12
Timeframe: 3 months
Secondary Outcome Measures
Time to PASI 75 responses
Timeframe: Variable
Proportion of subjects achieving PASI 90 at Week 12
Timeframe: 3 months
Improvement in PASI at Week 12
Timeframe: 3 months
Improvement in body surface area (BSA) involved with psoriasis at Week 12
Timeframe: 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
Timeframe: 3 months
Improvement in patient global assesssment of psoriasis at Week 12
Timeframe: 3 months
Improvement in Dermatology Life Quality Index (DLQI) at Week 12
Timeframe: 3 months
Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12
Timeframe: 3 months
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.