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Etanercept Plus UVB-311nm Phototherapy in Psoriasis
This study is currently recruiting participants.
Study NCT00550030   Information provided by Medical University of Graz
First Received: October 24, 2007   Last Updated: September 29, 2009   History of Changes

October 24, 2007
September 29, 2009
August 2006
December 2009   (final data collection date for primary outcome measure)
Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ] [ Designated as safety issue: No ]
Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ]
Complete list of historical versions of study NCT00550030 on ClinicalTrials.gov Archive Site
Patient disease and life quality score [ Time Frame: prospective ] [ Designated as safety issue: No ]
Patient disease and life quality score [ Time Frame: prospective ]
 
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.

 
Interventional
Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Psoriasis
  • Radiation: UVB-311nm radiation
  • Other: No treatment
Experimental: half-body comparison
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
17
December 2010
December 2009   (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
Both
18 Years and older
No
Contact: Peter Wolf, MD +43 316-385 ext 3254 peter.wolf@meduni-graz.at
Contact: Angelika Hofer, MD +43 316 385 ext 3254 angelika.hofer@meduni-graz.at
Austria
 
NCT00550030
Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria
17-257 ex 05/06
Medical University of Graz
 
Principal Investigator: Peter Wolf, MD Dept. of Dermatology, Medical University of Graz, Graz, Austria
Medical University of Graz
September 2009

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