Objective Study in Rheumatoid Arthritis
Primary Objectives
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.
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
To establish the relationship between achieving a given STO or combination of STOs and damage progression.
To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.
Status: Completed (Phase 4). Started on March 1st, 2002.
Enrollment: 249 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Single Blind
- Uncontrolled
- Single Group Assignment
- Safety/Efficacy Study
Conditions:
Interventions:
- Drug: LEFLUNOMIDE
Eligibility
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
Both
- Mininum Age
18 Years
- Maximum Age
75 Years
- Healthy Volunteers
No
Resources
Source: Sanofi-Aventis
Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Locations
-
Sanofi-Aventis
Sydney
Australia
Officials
J Edmonds (Principal Investigator, Sanofi-Aventis)
Sponsors
Sanofi-Aventis (Lead Sponsor)
References
None.
Links
- Date Verified
- September 1st, 2008
- First Received
- September 4th, 2008
- Last Changed
- September 4th, 2008
Information obtained from ClinicalTrials.gov on September 05, 2008. Link to the current ClinicalTrials.gov record.
All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.
The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.