Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111410
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2005-05-20
Brief Title:
Evaluating the Effect of Anakinra r-metHuIL-1ra on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis RA
Sponsor:
Amgen
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Placebo Controlled Study to Estimate the Effect of Anakinra r-metHuIL-1ra on Vaccine Antibody Response in Subjects With Rheumatoid Arthritis RA
Status:
COMPLETED
Status Verified Date:
2016-08
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:
The purpose of this study is to estimate the effect of anakinra 100 mg once daily QD on the development of an anti-tetanus antibody response in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection In addition this study will evaluate the general safety profile of therapy with anakinra 100 mg QD in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection
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