Etanercept Plus UVB-311nm Phototherapy in Psoriasis

NCT ID: NCT00550030

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-12-31

Brief Summary

Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept.

Detailed Description

Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter on a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to < 3) for a maximum of another 6 weeks (until week 12). PASI score and patient disease score is assessed weekly; patient life quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12. Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease and life quality 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

half-body comparison

Group Type: EXPERIMENTAL

UVB-311nm radiation

Intervention Type: RADIATION

UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.

No treatment

Intervention Type: OTHER

no UV exposure

Interventions

UVB-311nm radiation

UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.

Intervention Type: RADIATION

No treatment

no UV exposure

Intervention Type: OTHER

Other Intervention Names

Narrow band UVB radiation

Eligibility Criteria

Inclusion Criteria

• Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater

Exclusion Criteria

• Pregnancy or lactation
• 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

Dept. of Dermatology, Medical University of Graz, Graz, Austria

Locations

Medical University of Graz, Department of Dermatology

Graz, , Austria

Countries

Austria

Other Identifiers

17-257 ex 05/06

Identifier Type: -

Identifier Source: org_study_id