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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014