Prospective Study of the Combination of Golimumab and UVB-311nm Phototherapy in Patients With Psoriatic Arthritis and Psoriatic Skin Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years
- •Patients with psoriatic arthritis who receive treatment with golimumab
- •Patient wish for treatment of psoriatic skin lesions
Exclusion Criteria
- •Pregnancy or lactation
- •Presence and/or history of malignant melanoma
- •Presence and/or history of invasive squamous cell carcinoma of the skin
- •Presence and/or history of more than 3 basal cell carcinomas
- •Dysplastic nevus syndrome
- •Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
- •Autoimmune disorders such as lupus erythematosus or dermatomyositis
- •Abnormal photosensitivity and photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- •General poor health status
Outcomes
Primary Outcomes
Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site
Time Frame: week 6
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.
Secondary Outcomes
- Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions(week 6)
Investigators
Peter Wolf, MD
Professor of Bioimmunotherapy
Medical University of Graz