Objective Study in Rheumatoid Arthritis (OSRA)
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451971
|Principal Investigator:||J Edmonds||Sanofi|