Objective Study in Rheumatoid Arthritis (OSRA)
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
LEFLUNOMIDE
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome 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 Outcome Measures
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00451971
Brief Title
Objective Study in Rheumatoid Arthritis
Acronym
OSRA
Official Title
Objective Study in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LEFLUNOMIDE
Primary Outcome Measure Information:
Title
Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
Title
The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
Title
C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
Secondary Outcome Measure Information:
Title
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Edmonds
Organizational Affiliation
Sanofi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis
City
Sydney
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
23118111
Citation
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.
Results Reference
derived
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Objective Study in Rheumatoid Arthritis
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