Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects - Tabular View

Tracking Information

First Received Date ^ICMJE

April 10, 2008

Last Updated Date

September 22, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects treated with alefacept and nbUVB who achieve Psoriasis Area and Severity Index (PASI) 75 as compared to subjects treated with alefacept alone [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00658606 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Body Surface Area (BSA) covered with psoriasis for subjects treated with alefacept in combination with nbUVB as compared to subjects treated with alefacept alone [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

Official Title ^ICMJE

Efficacy and Safety of Alefacept in Combination With Narrow-band UVB (nbUVB) Compared to Alefacept Alone in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Brief Summary

Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Plaque Psoriasis

Intervention ^ICMJE

Drug: alefacept
Procedure: Narrow Band UVB Phototherapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject has given written informed consent
Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a PASI score >=10 at Baseline
Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
Male and female subjects must use an adequate means of contraception from screening to end of study.

Exclusion Criteria:

Subject who received alefacept in the past
Subject who has shown no improvement following an adequate course of nbUVB in the past
Subject who has been treated in the past with either therapy or cyclosporine
Subject with any active cancer, including skin cancer at Baseline
Subject with erythrodermic, pustular or predominantly guttate psoriasis
Subject who has used treatment for psoriasis prior to Baseline as follows:
- Topical treatment within 14 days
- Oral treatment within 28 days
- bbUVB or nbUVB treatment within 56 days
- Biological treatment within 84 days
Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug
Subject with a history of drug or alcohol abuse within the past 2 years
Subject that is known to be infected with the AIDS virus
Subject with any other skin disease or other disease that might interfere with psoriasis status assessments
Female subject who is nursing, pregnant or planning to become pregnant while in this study
Subject who is currently enrolled in any other investigational drug or device study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00658606

Responsible Party

Sr Manager Clinical Trials Registry, Astellas Pharma Global Development

Study ID Numbers ^ICMJE

AME-001

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Astellas Pharma Canada, Inc.

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma Canada, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP