Alefacept Mechanism of Action in Psoriasis

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Mechanism of action of alefacept

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, alefacept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UMDNJ Clinical Research Center

Outcomes

Primary Outcome Measures

To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo

Secondary Outcome Measures

To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.

Full Information

NCT ID

NCT00150982

First Posted

September 6, 2005

Last Updated

August 6, 2008

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00150982

Brief Title

Alefacept Mechanism of Action in Psoriasis

Official Title

In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Biogen

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

psoriasis, alefacept

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Mechanism of action of alefacept

Primary Outcome Measure Information:

Title

To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo

Secondary Outcome Measure Information:

Title

To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alice Gottlieb, MD, PhD

Organizational Affiliation

Rutgers, The State University of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

UMDNJ Clinical Research Center

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Psoriasis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial