Not provided
Not provided
Not provided
Not provided
Not provided
Difficulties in recruiting patients;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UVB-311nm radiation | Radiation | UVB-311nm radiation given 3 times a week to one randomized body-half |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site | 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. | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions | week 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Wolf, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8036 | Austria |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided