Objective Study in Rheumatoid Arthritis
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...
Brief Summary
Official Title: “Objective Study in Rheumatoid Arthritis”
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
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: LEFLUNOMIDE
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
J Edmonds Principal Investigator Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00451971
Study ID Number: HWA486_4020
ClinicalTrials.gov Identifier: NCT00451971
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00451971
