Etanercept Plus UVB-311nm Phototherapy in Psoriasis
Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment|
- Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Patient disease and life quality score [ Time Frame: prospective ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Radiation: UVB-311nm radiation
UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.
Other Name: Narrow band UVB radiationOther: No treatment
no UV exposure
Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter on a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to < 3) for a maximum of another 6 weeks (until week 12). PASI score and patient disease score is assessed weekly; patient life quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12. Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease and life quality scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75%, and/or 50% between body sites.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550030
|Medical University of Graz, Department of Dermatology|
|Graz, Austria, A-8036|
|Principal Investigator:||Peter Wolf, MD||Dept. of Dermatology, Medical University of Graz, Graz, Austria|