Alefacept (Amevive) With or Without Narrowband UVB Treatment in Patients With Psoriasis. - Full Text View

Sponsor:	Medical University of Graz
Information provided by:	Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00407342

Purpose

Alefacept is a new anti-psoriatic drug within the group of the so-called biologics. In about 30% of patients alefacept induces a more than 75% improvement of psoriasis after a 12-week treatment period. The start of anti-psoriatic effect by alefacept is delayed, however improvement of psoriatic lesions outlasts the end of alefacept treatment.

Narrowband UVB (UVB-311nm) phototherapy is an established anti-psoriatic treatment regimen with rapid onset of anti-psoriatic efficacy but disease-free intervals after the end of successful treatment courses may be short.

Therefore, in this half-side (left/right side) comparison study we aim to investigate whether an additional narrowband UVB treatment accelerates and improves the anti-psoriatic treatment effects of alefacept.

Condition	Intervention
Psoriasis	Drug: Alefacept (drug) Procedure: Narrowband UVB phototherapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Prospective, Randomized Half-side Comparison of Alefacept (Amevive) With or Without UVB-311nm Phototherapy in Patients With Psoriasis (Translated From German)

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Alefacept

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: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

VAS for therapeutic effect; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
VAS for severity of skin lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	February 2004
Study Completion Date:	September 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Intervention Details:

alefaceptgiven iv

Detailed Description:

Psoriasis is an inflammatory skin disease that affects an estimated 2% to 3% of the world's population. There are a wide range of local and systemic clinical treatments and agents for clearing, or at least reducing the expression of, psoriatic skin lesions. There is a new generation of antipsoriatic drugs that specifically target T-cell mediated inflammatory pathways and that are approved for the treatment of moderate to severe psoriasis in the United States. Alefacept (Amevive) is one of these so-called biologics. Alefacept appears to have several advantages over other systemic antipsoriatic agents and is very well tolerated by patients. Weekly administration of alefacept for 12 weeks reduced the psoriasis area and severity index (PASI) by greater than 75% in 30% of patients. The maximal antipsoriatic effect, however, apparently occurs after the 12-week course has ended. In vitro studies and previous case reports suggested that alefacept's antipsoriatic effect may be augmented when it is administered in combination with UVB. These findings prompted us to conduct a prospective randomized half-body comparison study, in which we ask whether the clinical response of psoriatic lesions to alefacept could be improved by combining alefacept with standard UVB 311nm phototherapy.

Comparison: Psoriatic patients are treated with intravenous alefacept once per week for 12 weeks. One randomized chosen body-half (left or right side) is additionally treated with narrowband UVB (UVB-311nm) three times per week until complete clearance of psoriatic lesions at the UV-treated side. PASI is evaluated before, weekly during, and for 3 to 12 months after alefacept +/- narrowband UVB treatment.

Eligibility

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

Criteria

Inclusion Criteria:

Moderate to severe plaque-type psoriasis;
disease duration for more than 6 months
PASI above 10.

Exclusion Criteria:

age < 18 years;
pregnancy or lactation;
presence of a dysplastic nevus syndrome;
photosensitive skin disease;
autoimmune disease;
severe renal or hepatic disease;
presence or history of malignant skin tumors;
presence of antinuclear antibodies;
history of previous treatments with arsenic, methotrexate, or x-rays;
within the last 4 weeks before enrollment into the study, UVB or PUVA treatment, immunosuppressive/-modulating drugs (such as corticosteroids, cyclosporine, and biologics such as infliximab, etanercept or efalizumab).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407342

Locations

Austria, Styria
Medical University of Graz
Graz, Styria, Austria, A-8036

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator:

Peter Wolf, MD

Research Unit for Photodermatology, Department of Dermatology, Medical University Graz

More Information

No publications provided by Medical University of Graz

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Legat FJ, Hofer A, Wackernagel A, Salmhofer W, Quehenberger F, Kerl H, Wolf P. Narrowband UV-B phototherapy, alefacept, and clearance of psoriasis. Arch Dermatol. 2007 Aug;143(8):1016-22.

Responsible Party:	Medical University of Graz, Austria ( Peter Wolf, MD, Principal Investigator )
Study ID Numbers:	14-075ex03/04
Study First Received:	December 4, 2006
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00407342 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:

Psoriasis
biologics
alefacept

Narrowband UVB
Phototherapy
Half-side comparison

Additional relevant MeSH terms:

Alefacept
Skin Diseases
Psoriasis
Therapeutic Uses

Dermatologic Agents
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010