Golimumab Plus UVB-311nm in Psoriasis

Not Applicable

Terminated

• Conditions: Psoriasis

• Registration Number: NCT01088698
• Lead Sponsor: Medical University of Graz

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site	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 Outcome Measures

Name	Time	Method
Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions	week 6

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria