Objective Study in Rheumatoid Arthritis (OSRA)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: LEFLUNOMIDE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451971

HWA486_4020

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind