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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407342
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : September 30, 2009
Information provided by:
Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Alefacept (drug) Procedure: Narrowband UVB phototherapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Half-side Comparison of Alefacept (Amevive) With or Without UVB-311nm Phototherapy in Patients With Psoriasis (Translated From German)
Study Start Date : February 2004
Actual Primary Completion Date : June 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Intervention Details:
  • Drug: Alefacept (drug)
    alefaceptgiven iv
    Other Name: Amevive
  • Procedure: Narrowband UVB phototherapy

Primary Outcome Measures :
  1. Modified PASI (Psoriasis area and severity index) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. VAS for therapeutic effect; [ Time Frame: 6 months ]
  2. VAS for severity of skin lesions [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407342

Medical University of Graz
Graz, Styria, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Peter Wolf, MD Research Unit for Photodermatology, Department of Dermatology, Medical University Graz

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria Identifier: NCT00407342     History of Changes
Other Study ID Numbers: 14-075ex03/04
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009

Keywords provided by Medical University of Graz:
Narrowband UVB
Half-side comparison

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents