Study Complete
Sponsor ID
20040171

Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis

Sponsor ID
20040171
Clinicaltrials.gov ID
NCT00110981
EUCTIS ID
N/A
EudraCT ID
N/A

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).

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
86
Additional Study Details

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.