Golimumab Plus UVB-311nm in Psoriasis

NCT ID: NCT01088698

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-10-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

UVB-311nm radiation

UVB-311nm radiation given 3 times a week to one randomized body-half

Intervention Type: RADIATION

Other Intervention Names

narrow-band UVB radiation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Peter Wolf, MD

Professor of Bioimmunotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Austria

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

21-110 ex 09/10

Identifier Type: -

Identifier Source: org_study_id