Primary UVB-311nm and Adalimumab in Psoriasis Patients

NCT ID: NCT00638261

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-08-31

Brief Summary

Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.

Detailed Description

Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) 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). 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. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer 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

Study Groups

left/right

left or right body side

Group Type: OTHER

UVB-311nm

Intervention Type: RADIATION

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

Interventions

UVB-311nm

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

• Psoriasis patients who are scheduled for treatment with adalimumab.

Exclusion Criteria

• Pregnancy or lactation
• History of skin cancer
• Presence of or history of malignant skin tumors
• Dysplastic melanocytic nevus syndrome
• Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
• Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
• 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, Department of Dermatology

Graz, , Austria

Countries

Austria

Other Identifiers

19-134 ex 07/08

Identifier Type: -

Identifier Source: org_study_id