Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab
Patients with moderate to severe psoriasis who have received treatment with adalimumab
(loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a
PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and
UVB-311nm phototherapy is added at 6 weeks or thereafter one 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, visual analogue score (VAS)
patient score for therapeutic response, and VAS patient score for severity of skin lesions
is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing
for differences in PASI and patient VAS scores is done; Fischer exact test is applied to
determine differences in complete remission, PASI reduction > 90%, > 75% and/or 50% between
body sites.
Interventional
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Modified PASI (psoriasis area and severity index)
12 months
No
Peter Wolf, MD
Principal Investigator
Medical University of Graz, Austria
Austria: Federal Ministry for Health and Women
19-133 ex 07/08
NCT00638469
March 2008
December 2013
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