NCT00550030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

4.3 years

First QC Date

October 24, 2007

Last Update Submit

March 15, 2012

Conditions

Psoriasis

Keywords

PsoriasisUVB radiationBiologicsEtanerceptPASI

Outcome Measures

Primary Outcomes (1)

  • Reduction of PASI (psoriasis activity score index)

    prospective

Secondary Outcomes (1)

  • Patient disease and life quality score

    prospective

Study Arms (1)

left/right

EXPERIMENTAL

half-body comparison

Radiation: UVB-311nm radiationOther: No treatment

Interventions

UVB-311nm radiationRADIATION

UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.

Also known as: Narrow band UVB radiation
left/right
No treatmentOTHER

no UV exposure

left/right

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Department of Dermatology

Graz, A-8036, Austria

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter Wolf, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Bioimmunotherapy

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 26, 2007

Study Start

August 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

AU(1)