Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458861
Status:
TERMINATED
Last Update Posted:
2016-01-21
First Post:
2007-03-22
Brief Title:
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase 2b Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy Safety PK and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis of data failed to meet primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously SC versus placebo in participants with active rheumatoid arthritis RA who have previously had an inadequate response to treatment with anti-tumor necrosis factor anti-TNF therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-005467-26 | EUDRACT_NUMBER | None | None |