Arthritis, Rheumatoid
Conditions
Brief 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.
Interventions
DRUGLEFLUNOMIDE
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event) | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test | — |
Countries
Australia
Outcome results
None listed