Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 5:14 PM
Study NCT ID:
NCT01534403
Status:
COMPLETED
Last Update Posted:
2016-05-06
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
Sponsor:
UCB Pharma
Organization:
Study Overview
Official Title:
A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2016-04
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 study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 \[NCT01449071\] phase I/II trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: