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
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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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: LEFLUNOMIDE Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Objective Study in Rheumatoid Arthritis
Study Start Date : March 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Primary Outcome Measures :
  1. Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
  2. The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
  3. C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)

Secondary Outcome Measures :
  1. Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00451971

Sydney, Australia
Sponsors and Collaborators
Principal Investigator: J Edmonds Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00451971     History of Changes
Obsolete Identifiers: NCT00251667
Other Study ID Numbers: HWA486_4020
First Posted: March 26, 2007    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents