Objective Study in Rheumatoid Arthritis

Phase 4CompletedNCT00451971

Sanofi249 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

249

Conditions

Arthritis, Rheumatoid

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)

Secondary Outcomes

Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test