UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis
Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 1, 2013
October 1, 2013
6.8 years
March 12, 2008
October 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified PASI (psoriasis area and severity index)
12 months
Secondary Outcomes (2)
VAS patient score for therapeutic effect
12 months
VAS patient score for severity of skin lesions
12 months
Study Arms (1)
left/right
OTHERleft or right body side
Interventions
UVB-311nm radiation given 3 times a week to one randomized body half
Eligibility Criteria
You may qualify if:
- Psoriasis patients with PASI reduction of less than 75% after at least 6 weeks of treatment with adalimumab.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz, Department of Dermatology
Graz, A-8036, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Wolf, MD
Medical University of Graz, Austria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Bioimmunotherapy
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 19, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
November 1, 2013
Record last verified: 2013-10