Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451971
Status:
COMPLETED
Last Update Posted:
2008-09-05
First Post:
2007-03-23
Brief Title:
Objective Study in Rheumatoid Arthritis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Objective Study in Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2008-09
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:
OSRA
Brief Summary:
Primary Objectives
1 To test the feasibility in patients with active rheumatoid arthritis of using an aggressive treatment algorithm to bring a short term treatment objective STO within the normal or an arbitrarily defined desirable range
2 To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care
Secondary Objectives
1 To establish the relationship between achieving a given STO or combination of STOs and damage progression
2 To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression
1 To test the feasibility in patients with active rheumatoid arthritis of using an aggressive treatment algorithm to bring a short term treatment objective STO within the normal or an arbitrarily defined desirable range
2 To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care
Secondary Objectives
1 To establish the relationship between achieving a given STO or combination of STOs and damage progression
2 To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression
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