Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430495
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2007-01-30
Brief Title:
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis AUGUST I
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicentre Phase II Dose-finding Study of Atacicept Given Subcutaneously in Subjects With Rheumatoid Arthritis and Inadequate Response to TNFa Antagonist Therapy
Status:
COMPLETED
Status Verified Date:
2016-01
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:
AUGUST I
Brief Summary:
This was a double-blind placebo-controlled parallel-arm multicentre prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha TNFa antagonist due to lack of efficacy
Detailed Description:
None
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