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Objective Study in Rheumatoid Arthritis (OSRA)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00451971
First received: March 23, 2007
Last updated: September 4, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention Phase
Arthritis, Rheumatoid
 Drug: LEFLUNOMIDE
 Phase 4

Study Type: Interventional
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:

Drug Information available for: Leflunomide
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

Enrollment: 249
Study Start Date: March 2002
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451971

Locations
Australia
Sanofi-Aventis
Sydney, Australia
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: J Edmonds Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00451971     History of Changes
Obsolete Identifiers: NCT00251667
Other Study ID Numbers: HWA486_4020
Study First Received: March 23, 2007
Last Updated: September 4, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on May 22, 2013