Objective Study in Rheumatoid Arthritis (OSRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451971
Recruitment Status : Completed
First Posted : March 26, 2007
Last Update Posted : September 5, 2008
Information provided by:

March 23, 2007
March 26, 2007
September 5, 2008
March 2002
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00451971 on Archive Site
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Same as current
Not Provided
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Objective Study in Rheumatoid Arthritis
Objective Study in Rheumatoid Arthritis

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.
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Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Arthritis, Rheumatoid
Not Provided
Poh MQ, Lassere M, Bird P, Edmonds J. Reliability and longitudinal validity of computer-assisted methods for measuring joint damage progression in subjects with rheumatoid arthritis. J Rheumatol. 2013 Jan;40(1):23-9. doi: 10.3899/jrheum.120549. Epub 2012 Nov 1.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either
  • Active disease: ≥6/28 swollen joints or
  • Erythrocyte sedimantation or C-Reactive Protein > normal
  • Disease duration ≤ 15 yrs
  • Any therapy
  • Females of child-bearing potential must be adequate contraception

Exclusion Criteria:

  • Frailty, limiting co-morbidity
  • Obesity limiting ability to have MRI
  • Geographical difficulty preventing follow-up and visits
  • Women at risk of becoming pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Medical Affairs Study Director, sanofi-aventis
Not Provided
Principal Investigator: J Edmonds Sanofi
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP