UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis

Psoriasis Clinical Trial

Official title:

Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00638469
• Other study ID #: 19-133 ex 07/08
• Status: Unknown status
• Phase: N/A
• First received: March 12, 2008
• Last updated: October 31, 2013
• Start date: March 2008
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: Medical University of Graz
• Contact: Peter Wolf, MD
• Phone: +43 316 385
• Email: peter.wolf[@]medunigraz.at
• Is FDA regulated: No
• 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 additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.

Description:

Patients with moderate to severe psoriasis who have received treatment with adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter one 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, visual analogue score (VAS) patient score for therapeutic response, and VAS patient score 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: Unknown status
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Psoriasis patients with PASI reduction of less than 75% after at least 6 weeks of 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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Other:
• No treatment
no UV exposure

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
Secondary	VAS patient score for therapeutic effect		12 months
Secondary	VAS patient score for severity of skin lesions		12 months