Objective Study in Rheumatoid Arthritis

Sanofi1 site in 1 country249 target enrollmentMarch 2002

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Arthritis, Rheumatoid
Sponsor: Sanofi
Enrollment: 249
Locations: 1
Primary Endpoint: Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
Status: Completed
Last Updated: 17 years ago

Primary Objectives

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.
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

To establish the relationship between achieving a given STO or combination of STOs and damage progression.
To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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

•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.