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Community Based Trial for AMEVIVE®

Primary Purpose

Moderate to Severe Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Alefacept
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Chronic Plaque Psoriasis focused on measuring Extended dosing, alefacept

Eligibility Criteria

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

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.

Sites / Locations

  • Monheit Dermatology Associates
  • Bayshore Dermatology
  • Jayne Fortson
  • Bakersfield Dermatology & Skin Cancer Medical Group
  • Integrated Research Group
  • Robert Greenberg
  • Front Dermatology
  • Skin and Cancer Associates
  • Michael Scannon
  • Atlanta Derm, Vein & Research Center
  • Pearlridge Dermatology
  • Altman Dermatology Associates
  • Calumet Dermatology Associates
  • Michael Greenberg
  • David J. Coynik
  • Melissa Knuckles
  • Richard Eisen
  • Psoriasis Treatment Center
  • Woodson Clinical Studies Group, Inc.
  • Nashua Dermatology
  • Jerry Bagel
  • Catskill Dermatology
  • Marina I Peredo
  • Buffalo Medical Group
  • Wilmington Health Associates Dermatology
  • Robert Brodell
  • Dermatology & Laser Center of Roseberg
  • Dermatology Assoc of Plymouth Meeting
  • Dermatology Associates of Knoxville
  • Gold Skin Care
  • Bellaire Dermatology Associates
  • Texas Dermatology Research
  • Mark Wallis
  • Stephen Miller
  • Stephen Flax
  • Dermatology & Laser Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

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.

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,
The cumulative change in PQA score from screening visit to best PQA score at any time in the study,
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 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,
The cumulative change in SSA score from screening visit to best SSA score at any time in the study,
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
Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.

Full Information

First Posted
September 13, 2005
Last Updated
September 5, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00168753
Brief Title
Community Based Trial for AMEVIVE®
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Chronic Plaque Psoriasis
Keywords
Extended dosing, alefacept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Alefacept
Other Intervention Name(s)
Amevive, ASP0485
Intervention Description
IM
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
The cumulative change in PQA score from screening visit to best PQA score at any time in the study,
Time Frame
End of study
Title
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
Title
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
Title
The cumulative change in SSA score from screening visit to best SSA score at any time in the study,
Time Frame
End of study
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gold
Organizational Affiliation
GoldSkin Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monheit Dermatology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
Bayshore Dermatology
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Jayne Fortson
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99501
Country
United States
Facility Name
Bakersfield Dermatology & Skin Cancer Medical Group
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Integrated Research Group
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Robert Greenberg
City
San Ramon
State/Province
California
ZIP/Postal Code
94582
Country
United States
Facility Name
Front Dermatology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Skin and Cancer Associates
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Michael Scannon
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Atlanta Derm, Vein & Research Center
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30004
Country
United States
Facility Name
Pearlridge Dermatology
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Calumet Dermatology Associates
City
Calumet City
State/Province
Illinois
ZIP/Postal Code
60477
Country
United States
Facility Name
Michael Greenberg
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
David J. Coynik
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Melissa Knuckles
City
Corbin
State/Province
Kentucky
ZIP/Postal Code
40701
Country
United States
Facility Name
Richard Eisen
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Psoriasis Treatment Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Woodson Clinical Studies Group, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Nashua Dermatology
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Jerry Bagel
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08512
Country
United States
Facility Name
Catskill Dermatology
City
Monticello
State/Province
New York
ZIP/Postal Code
12701
Country
United States
Facility Name
Marina I Peredo
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Buffalo Medical Group
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Wilmington Health Associates Dermatology
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Robert Brodell
City
Warren
State/Province
Ohio
ZIP/Postal Code
44481
Country
United States
Facility Name
Dermatology & Laser Center of Roseberg
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97470
Country
United States
Facility Name
Dermatology Assoc of Plymouth Meeting
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Dermatology Associates of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37902
Country
United States
Facility Name
Gold Skin Care
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37201
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Texas Dermatology Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Mark Wallis
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Stephen Miller
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Stephen Flax
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Dermatology & Laser Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140573 in the JapicCTI-RNo. field

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Community Based Trial for AMEVIVE®

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