Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
249 participants
INTERVENTIONAL
2002-03-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Interventions
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LEFLUNOMIDE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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J Edmonds
Role: PRINCIPAL_INVESTIGATOR
Sanofi
Locations
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Sanofi-Aventis
Sydney, , Australia
Countries
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References
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Poh MQ, Lassere M, Bird P, Edmonds J. Reliability and longitudinal validity of computer-assisted methods for measuring joint damage progression in subjects with rheumatoid arthritis. J Rheumatol. 2013 Jan;40(1):23-9. doi: 10.3899/jrheum.120549. Epub 2012 Nov 1.
Other Identifiers
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HWA486_4020
Identifier Type: -
Identifier Source: org_study_id
NCT00251667
Identifier Type: -
Identifier Source: nct_alias