Etanercept Plus UVB-311nm Phototherapy in Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00550030
First received: October 24, 2007
Last updated: March 15, 2012
Last verified: March 2012

October 24, 2007
March 15, 2012
August 2006
December 2010   (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 ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
  • 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
Interventions:
  • 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.
 
Completed
6
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00550030
17-257 ex 05/06
No
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