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Etanercept Plus UVB-311nm Phototherapy in Psoriasis

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ClinicalTrials.gov Identifier: NCT00550030
Recruitment Status : Completed
First Posted : October 26, 2007
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):

October 24, 2007
October 26, 2007
March 16, 2012
August 2006
December 2010   (Final data collection date for primary outcome measure)
Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ]
Same as current
Complete list of historical versions of study NCT00550030 on ClinicalTrials.gov Archive Site
Patient disease and life quality score [ Time Frame: prospective ]
Same as current
Not Provided
Not Provided
Etanercept Plus UVB-311nm Phototherapy in Psoriasis
Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment
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.
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.
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Radiation: 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.
    Other Name: Narrow band UVB radiation
  • Other: No treatment
    no UV exposure
Experimental: left/right
half-body comparison
  • Radiation: UVB-311nm radiation
  • Other: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
17-257 ex 05/06
Not Provided
Not Provided
Peter Wolf, MD, Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Peter Wolf, MD Dept. of Dermatology, Medical University of Graz, Graz, Austria
Medical University of Graz
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP