Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-10 @ 11:16 PM
Study NCT ID:
NCT00624351
Status:
COMPLETED
Last Update Posted:
2011-09-12
First Post:
2008-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
Sponsor:
UCB Pharma
Organization:
Study Overview
Official Title:
A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
Status:
COMPLETED
Status Verified Date:
2011-07
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 primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-002566-35 | EUDRACT_NUMBER | None | View |