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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00407342
First received: December 4, 2006
Last updated: September 29, 2009
Last verified: September 2009
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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:
    Drug: Alefacept (drug)
    alefaceptgiven iv
    Other Name: Amevive
    Procedure: Narrowband UVB phototherapy
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00407342

Locations
Austria
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria
ClinicalTrials.gov Identifier: NCT00407342     History of Changes
Other Study ID Numbers: 14-075ex03/04
Study First Received: December 4, 2006
Last Updated: September 29, 2009
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:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Alefacept
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014