Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: LEFLUNOMIDE

Primary 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 Measures

• Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

J Edmonds Principal Investigator Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00451971

Study ID Number: HWA486_4020

ClinicalTrials.gov Identifier: NCT00451971

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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