Objective Study in Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT00451971
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-23
• Study First Posted: 2007-03-26
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-04
• Last Update Posted: 2008-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇦🇺 Sydney, Australia