Primary UVB-311nm and Adalimumab in Psoriasis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00638261
First received: March 12, 2008
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Psoriasis
Radiation: UVB-311nm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Modified PASI (psoriasis area and severity index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient visual analogue score (VAS) for therapeutic effect [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient VAS for severity of skin lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: March 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
left/right
left or right body side
Radiation: UVB-311nm
UVB-311nm radiation given 3 times a week to one randomized body-half
Other Name: narrow-band UVB radiation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638261

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 Medical University of Graz, Austria
  More Information

No publications provided

Responsible Party: Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00638261     History of Changes
Other Study ID Numbers: 19-134 ex 07/08
Study First Received: March 12, 2008
Last Updated: March 15, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:
Psoriasis
Biologic
Adalimumab
Narrow-band UVB
phototherapy
half-side comparison

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014