Skip to main content
OpenTrials
Completed

NCT Number: NCT00638261

Primary UVB-311nm and Adalimumab in Psoriasis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Department of Dermatology

Graz, A-8036, Austria

About this study

Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to < 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75% and/or 50% between body sites.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Psoriasis patients who are scheduled for treatment with adalimumab.

Exclusion criteria

  • 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

Treatment and study plan

UVB-311nm

Radiation

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

Other names: narrow-band UVB radiation

Primary outcomes

  1. Modified PASI (psoriasis area and severity index)

    Time frame: 12 months

Secondary outcomes

  1. Patient visual analogue score (VAS) for therapeutic effect

    Time frame: 12 months

  2. Patient VAS for severity of skin lesions

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 19, 2008
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.