Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292422
Status:
COMPLETED
Last Update Posted:
2007-12-31
First Post:
2006-02-15
Brief Title:
Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomized Blinded Placebo-Controlled Multicenter Dose-Escalating Study to Evaluate the Safety Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy
Status:
COMPLETED
Status Verified Date:
2007-12
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:
This Phase 2a study is designed to evaluate the safety and tolerability of multiple subcutaneous SC doses of BG9924 administered in a cohort dose-escalation fashion in patients with active rheumatoid arthritis RA who have had an inadequate response to therapy with disease-modifying anti rheumatic drugs DMARDs and who may have undergone anti-TNF therapy This study will assist with dose selection for further planned Phase 2 studies
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