Primary UVB-311nm and Adalimumab in Psoriasis Patients

Psoriasis Clinical Trial

Official title:

Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638261
• Other study ID #: 19-134 ex 07/08
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: March 15, 2012
• Start date: March 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department of Dermatology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified PASI (psoriasis area and severity index)		12 months	No
Secondary	Patient visual analogue score (VAS) for therapeutic effect		12 months	No
Secondary	Patient VAS for severity of skin lesions		12 months	No