Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-29 @ 1:41 AM
Study NCT ID:
NCT00131066
Status:
COMPLETED
Last Update Posted:
2008-09-22
First Post:
2005-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up Study of Psoriasis Patients
Sponsor:
MedImmune LLC
Organization:
Study Overview
Official Title:
Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507
Status:
COMPLETED
Status Verified Date:
2008-09
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:
The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.
Detailed Description:
This study will evaluate the long-term safety and lymphocyte repletion profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507. Patients must have had an ALC \> 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure); or an absolute CD4 count of \< 250 cells/uL. This study will also evaluate the development and durability of anti-MEDI-507 antibodies.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: