Community Based Trial for AMEVIVE® - Full Text View

Sponsors and Collaborators:	Astellas Pharma Inc Biogen Idec
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00168753

Purpose

To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

Condition	Intervention	Phase
Moderate to Severe Chronic Plaque Psoriasis	Drug: Alefacept	Phase IV

MedlinePlus related topics: Psoriasis

Drug Information available for: Alefacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE. [ Time Frame: 16 weeks, 20 weeks or 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, [ Time Frame: End of study ] [ Designated as safety issue: No ]
The cumulative change in PQA score from screening visit to best PQA score at any time in the study, [ Time Frame: End of study ] [ Designated as safety issue: No ]
Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study, [ Time Frame: End of study ] [ Designated as safety issue: No ]
Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, [ Time Frame: End of study ] [ Designated as safety issue: No ]
The cumulative change in SSA score from screening visit to best SSA score at any time in the study, [ Time Frame: End of study ] [ Designated as safety issue: No ]
Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and [ Time Frame: End of study ] [ Designated as safety issue: No ]
Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment:	114
Study Start Date:	July 2004
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Alefacept IM

Detailed Description:

Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.

Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must give written informed consent.
Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.
Must be 18 years of age or older.
Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.
Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present.

Exclusion Criteria:

Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.
Nursing mothers, pregnant women, and women planning to become pregnant
Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.
Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration.
Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration.
Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
History of >3 cutaneous squamous cell carcinomas or any systemic malignancy.
Skin lesions suspicious for malignancy.
Known HIV, viral hepatitis, or tuberculosis infection.
History of severe allergic or anaphylactic reactions.
ALT or AST greater than three times the upper limit of normal.
Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator.
CD4+ T lymphocyte count at screening visit less than 250 cells/mm3.
Known hypersensitivity to AMEVIVE or any of its components.
Subject's inability to comply with study requirements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168753

Show 36 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Biogen Idec

Investigators

Principal Investigator:

Michael Gold

GoldSkin Care

More Information

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	IST-US-064-04-AME, CBT/IST 64
Study First Received:	September 13, 2005
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00168753
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Extended dosing
alefacept

Study placed in the following topic categories:

Alefacept
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009