Objective Study in Rheumatoid Arthritis
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis, Rheumatoid
Intervention: LEFLUNOMIDE (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): J Edmonds, Principal Investigator, Affiliation: Sanofi
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.
Clinical Details
Official title: Objective Study in Rheumatoid Arthritis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: 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: Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis, Sydney, Australia
Additional Information
Starting date: March 2002
Last updated: September 4, 2008
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