Alefacept Mechanism of Action in Psoriasis | NCT00150982

Studies
Alefacept Mechanism of Action in Psoriasis

NCT00150982

Sponsor

University of Medicine and Dentistry of New Jersey

Status

Completed

Last Update Posted

Aug 7, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Psoriasis

Interventions

Mechanism of action of alefacept

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Feb 2005

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2008

Last Update Posted Date

Aug 7, 2008Estimated

Name	Class
Biogen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Mechanism of action of alefacept	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alice Gottlieb, MD, PhD	Rutgers, The State University of New Jersey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMDNJ Clinical Research Center		New Brunswick	New Jersey	08903	United States

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases