Alefacept (Amevive) With or Without Narrowband UVB Treatment in Patients With Psoriasis.

NCT00407342 | Completed

• 1 other identifier: 14-075ex03/04
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Keywords

Psoriasis; biologics; alefacept; Narrowband UVB; Phototherapy; Half-side comparison

Outcome Measures

Primary Outcomes (1)

• Modified PASI (Psoriasis area and severity index)

  6 months

Secondary Outcomes (2)

• VAS for therapeutic effect;

  6 months

• VAS for severity of skin lesions

  6 months

Interventions

Alefacept (drug) DRUG

alefaceptgiven iv

Also known as: Amevive

Narrowband UVB phototherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, A-8036, Austria

Location

Related Publications (1)

• 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. doi: 10.1001/archderm.143.8.1016.

  PMID: 17709660 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Alefacept; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• Peter Wolf, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: February 1, 2004
• Primary Completion: June 1, 2004
• Study Completion: September 1, 2004
• Last Updated: September 30, 2009

Record last verified: 2009-09

Locations

AU (1)