Etanercept Plus UVB-311nm Phototherapy in Psoriasis - Full Text View

Sponsor:	Medical University of Graz
Information provided by:	Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00550030

Purpose

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	Intervention
Psoriasis	Radiation: UVB-311nm radiation Other: No treatment

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:

Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient disease and life quality score [ Time Frame: prospective ] [ Designated as safety issue: No ]

Estimated Enrollment:	17
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
left/right: Experimental 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: No treatment no UV exposure

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550030

Contacts

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

Locations

Austria
Medical University of Graz, Department of Dermatology	Recruiting
Graz, Austria, A-8036
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
Sub-Investigator: Franz Legat, MD
Sub-Investigator: Angelika Hofer, MD
Sub-Investigator: Wolfgang Salmhofer, MD
Sub-Investigator: Alexandra Gruber-Wackernagel, MD

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator:

Peter Wolf, MD

Dept. of Dermatology, Medical University of Graz, Graz, Austria

More Information

No publications provided

Responsible Party:	Medical University of Graz, Austria ( Peter Wolf, MD, Principal Investigator )
Study ID Numbers:	17-257 ex 05/06
Study First Received:	October 24, 2007
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00550030 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:

Psoriasis
UVB radiation
Biologics
Etanercept
PASI

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 27, 2009