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

Not Applicable

• Conditions: Psoriasis
• Interventions: Radiation: UVB-311nm; Other: No treatment

• Registration Number: NCT00638469
• Lead Sponsor: Medical University of Graz

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 additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.

Detailed 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-19
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
left/right	UVB-311nm	left or right body side
left/right	No treatment	left or right body side

Primary Outcome Measures

Name	Time	Method
Modified PASI (psoriasis area and severity index)	12 months

Secondary Outcome Measures

Name	Time	Method
VAS patient score for therapeutic effect	12 months
VAS patient score for severity of skin lesions	12 months

Trial Locations

Locations (1)

Medical University of Graz, Department of Dermatology; 🇦🇹 Graz, Austria