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.

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.