Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111423
Status:
COMPLETED
Last Update Posted:
2009-03-06
First Post:
2005-05-20
Brief Title:
Evaluating the Safety of Extended Treatment With Pegsunercept PEG sTNF-RIin Subjects With Rheumatoid Arthritis RA
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety of Extended Treatment With Pegsunercept PEG sTNF-RI in Subjects With Rheumatoid Arthritis RA
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study 20000201 or 20000198 In addition this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis
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