Objective Study in Rheumatoid Arthritis (OSRA)
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|ClinicalTrials.gov Identifier: NCT00451971|
Recruitment Status : Completed
First Posted : March 26, 2007
Last Update Posted : September 5, 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.
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Drug: LEFLUNOMIDE||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Objective Study in Rheumatoid Arthritis|
|Study Start Date :||March 2002|
- 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)
- Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451971
|Principal Investigator:||J Edmonds||Sanofi|