Golimumab Plus UVB-311nm in Psoriasis
Golimumab, a TNF-alpha antibody, has been approved in the EC and USA for the treatment of psoriatic arthritis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic skin lesions in golimumab-treated patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Study of the Combination of Golimumab and UVB-311nm Phototherapy in Patients With Psoriatic Arthritis and Psoriatic Skin Lesions|
- Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site [ Time Frame: week 6 ] [ Designated as safety issue: No ]The effect of treatment on PASI will be determined. The primary hypothesis is that UVB-311nm treatment leads to a difference in the reduction of PASI from baseline by > 20% comparing the UV-irradiated vs. the non-irradiated body site at week 6 of treatment.
- Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions [ Time Frame: week 6 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Radiation: UVB-311nm radiation
Psoriatic skin lesions of patients with psoriatic arthritis who receive standard treatment with golimumab (50 mg or 100 mg s.c. once a month depending on total body weight whether below or above 100 kg, respectively) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to < 3). A patient qualifies if A) golimumab was started within a week or B) after 3 months of golimumab treatment the PASI reduction is smaller than 90%. PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. The primary hypothesis is that phototherapy increases the PASI reduction on the exposed body site by more than 20%. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fisher 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: NCT01088698
|Medical University of Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Peter Wolf, MD||Medical University of Graz, Austria|