Objective Study in Rheumatoid Arthritis (OSRA)
This study has been completed.
Information provided by:
First received: March 23, 2007
Last updated: September 4, 2008
Last verified: September 2008
- 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.
- 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.
- To establish the relationship between achieving a given STO or combination of STOs and damage progression.
- To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Objective Study in Rheumatoid Arthritis|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
- The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
- C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
Secondary Outcome Measures:
- Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
|Study Start Date:||March 2002|
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