NCT00638261

Brief Summary

Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

3.4 years

First QC Date

March 12, 2008

Last Update Submit

March 15, 2012

Conditions

Psoriasis

Keywords

PsoriasisBiologicAdalimumabNarrow-band UVBphototherapyhalf-side comparison

Outcome Measures

Primary Outcomes (1)

  • Modified PASI (psoriasis area and severity index)

    12 months

Secondary Outcomes (2)

  • Patient visual analogue score (VAS) for therapeutic effect

    12 months

  • Patient VAS for severity of skin lesions

    12 months

Study Arms (1)

left/right

OTHER

left or right body side

Radiation: UVB-311nm

Interventions

UVB-311nmRADIATION

UVB-311nm radiation given 3 times a week to one randomized body-half

Also known as: narrow-band UVB radiation
left/right

Eligibility Criteria

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

You may qualify if:

  • Psoriasis patients who are scheduled for treatment with adalimumab.

You may not qualify if:

  • Pregnancy or lactation
  • History of skin cancer
  • 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

    Medical University of 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

March 12, 2008

First Posted

March 19, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

AU(1)