Primary UVB-311nm and Adalimumab in Psoriasis Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

September 29, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638261 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Primary UVB-311nm and Adalimumab in Psoriasis Patients

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Radiation: UVB-311nm

Study Arms / Comparison Groups

Other: left or right body side

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Austria

Administrative Information

NCT ID ^ICMJE

NCT00638261

Responsible Party

Peter Wolf, MD, Medical University of Graz, Austria

Study ID Numbers ^ICMJE

19-134 ex 07/08

Study Sponsor ^ICMJE

Medical University of Graz

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Peter Wolf, MD

Medical University of Graz, Austria

Information Provided By

Medical University of Graz

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP