Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00168753
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2005-09-13
Brief Title:
Community Based Trial for AMEVIVE
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CBTIST 64 | None | None | None |