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Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
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 Psoriasis focused on measuring psoriasis, alefacept, intramuscular

Eligibility Criteria

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

Inclusion Criteria:

  • Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
  • Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728

Exclusion Criteria:

  • Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
  • Clinically significant abnormal hematology values or history of an immunosuppressive disorder
  • Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
  • A significant change in the subject's medical history from their previous alefacept study
  • Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
  • Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring

Secondary Outcome Measures

Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment

Full Information

First Posted
June 4, 2008
Last Updated
September 17, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00692172
Brief Title
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
Official Title
An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (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
An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, alefacept, intramuscular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
175 (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
intramuscular injection (IM)
Primary Outcome Measure Information:
Title
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
Time Frame
Throughout treatment course
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment
Time Frame
Every 2 weeks throughout treamtent course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR, Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728 Exclusion Criteria: Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study Clinically significant abnormal hematology values or history of an immunosuppressive disorder Serious local infection or systemic infection within 3 months prior to the first dose of alefacept A significant change in the subject's medical history from their previous alefacept study Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717 Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
79035
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C ON2
Country
Canada
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 4S8
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Brest
ZIP/Postal Code
29279
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Munich
ZIP/Postal Code
80337
Country
Germany
City
Amsterdam
ZIP/Postal Code
1100 DE
Country
Netherlands
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
Liverpool
ZIP/Postal Code
L14 3LB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20392521
Citation
Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140596 in the JapicCTI-RNo. field

Learn more about this trial

Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis

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