Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113971
Status:
TERMINATED
Last Update Posted:
2012-04-03
First Post:
2005-06-10
Brief Title:
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus SLE
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Randomized Phase II PharmacokineticsPharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus
Status:
TERMINATED
Status Verified Date:
2012-03
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:
The goal of this study is to evaluate how epratuzumab is processed by the body pharmacokinetics and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE
Detailed Description:
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels Additional information will be obtained related to the natural variability of disease activity in SLE patients
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