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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Psoriasis Radiation: UVB-311nm radiation Other: No treatment

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment
Study Start Date : August 2006
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: left/right
half-body comparison
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


Outcome Measures

Primary Outcome Measures :
  1. Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. Patient disease and life quality score [ Time Frame: prospective ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550030


Locations
Austria
Medical University of Graz, Department of Dermatology
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Peter Wolf, MD Dept. of Dermatology, Medical University of Graz, Graz, Austria
More Information

Responsible Party: Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00550030     History of Changes
Other Study ID Numbers: 17-257 ex 05/06
First Posted: October 26, 2007    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Peter Wolf, MD, Medical University of Graz:
Psoriasis
UVB radiation
Biologics
Etanercept
PASI

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors