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

Sponsored by:	Medical University of Graz
Information provided by:	Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00638469

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:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
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:

MedlinePlus related topics: Psoriasis Radiation Therapy

Drug Information available for: Adalimumab

U.S. FDA Resources

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 2010
Estimated Primary Completion Date:	December 2009 (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: 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@meduni-graz.at
Contact: Angelika Hofer, MD	+43 316 385 ext 80315	angelika.hofer@meduni-graz.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@meduni-graz.at
Contact: Angelika Hofer, MD +43 316 385 ext 3254 angelika.hofer@meduni-graz.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:	Principal Investigator, Medical University of Graz, Austria ( Peter Wolf, MD )
Study ID Numbers:	19-133 ex 07/08
Study First Received:	March 12, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00638469 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Skin Diseases
Psoriasis

Antirheumatic Agents
Adalimumab
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Skin Diseases
Psoriasis
Therapeutic Uses

Antirheumatic Agents
Adalimumab
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009