Objective Study in Rheumatoid Arthritis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Leflunomide

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.