Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 1:25 PM
Study NCT ID:
NCT00523328
Status:
TERMINATED
Last Update Posted:
2016-01-21
First Post:
2007-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Analysis of data from 104RA203 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 study is to observe the long-term treatment of BG9924
Detailed Description:
Extension study for 104RA203 (NCT 00458861)
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 |
|---|---|---|---|---|
| 2007-000734-38 | EUDRACT_NUMBER | None | View |