UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis

This study is currently recruiting participants.
Verified October 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00638469
First received: March 12, 2008
Last updated: October 31, 2013
Last verified: October 2013
  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 additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab

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:
  • VAS patient score for therapeutic effect [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • VAS patient score for severity of skin lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
Other: No treatment
no UV exposure

Detailed Description:

Patients with moderate to severe psoriasis who have received treatment with adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter one 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, visual analogue score (VAS) patient score for therapeutic response, and VAS patient score 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 with PASI reduction of less than 75% after at least 6 weeks of 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638469

Contacts
Contact: Peter Wolf, MD +43 316 385 ext 80315 peter.wolf@medunigraz.at
Contact: Angelika Hofer, MD +43 316 385 ext 80315 angelika.hofer@medunigraz.at

Locations
Austria
Medical University of Graz, Department of Dermatology Recruiting
Graz, Austria, A-8036
Contact: Peter Wolf, MD    +43 316 385 ext 80315    peter.wolf@medunigraz.at   
Contact: Angelika Hofer, MD    +43 316 385 ext 13254    angelika.hofer@medunigraz.at   
Principal Investigator: Peter Wolf, MD         
Sub-Investigator: Angelika Hofer, MD         
Sub-Investigator: Franz Legat, MD         
Sub-Investigator: Wolfgang Salmhofer, MD         
Sub-Investigator: Alexandra Gruber-Wackernagel, MD         
Sub-Investigator: Wolfgang Weger, MD         
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: NCT00638469     History of Changes
Other Study ID Numbers: 19-133 ex 07/08
Study First Received: March 12, 2008
Last Updated: October 31, 2013
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:
Psoriasis
Biologic
adalimumab
narrowband UVB
phototherapy
half-side comparison

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

ClinicalTrials.gov processed this record on April 23, 2014