Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-27 @ 5:44 PM
Study NCT ID:
NCT00442650
Status:
COMPLETED
Last Update Posted:
2016-11-21
First Post:
2007-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis
Sponsor:
Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-03
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:
Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments involved physical examination, disease activity assessments, clinical laboratory tests (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA). The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which other antipsoriatic medications were allowed. The same assessments were also performed in the 12-week FU period.
Detailed Description:
None
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?: