Alefacept Mechanism of Action in Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-02-28

Brief Summary

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To determine the mechanism of action of alefacept in patients with psoriasis.

Detailed Description

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The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.

Conditions

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Psoriasis

Keywords

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psoriasis alefacept

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mechanism of action of alefacept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).

Exclusion Criteria

* CD4 \< 400/ml
* WBC less than lower level of normal for the reporting laboratory
* \< 5% Body Surface Area involved with psoriasis
* Serious infection e.g., latent or active tuberculosis
* History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
* Systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of Alefacept
* Topical anti-psoriasis medications within 14 days of the first dose of Alefacept, except for moisturizers, tar shampoos (exception, Elidel is permitted to be applied on the face, groin and axillae areas. These areas are not biopsied.)
* Inability to understand consent form or comply with study requirements
* Pregnancy or lactation
* Concurrent medical illness that would make participation in this clinical trial ill-advised
* Any contraindications to using alefacept

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Alice Gottlieb, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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UMDNJ Clinical Research Center

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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4588

Identifier Type: -

Identifier Source: org_study_id