Golimumab Plus UVB-311nm in Psoriasis

Medical University of Graz

Status: Terminated

Conditions: Psoriasis

Treatments: Radiation: UVB-311nm radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01088698

21-110 ex 09/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)