Objective Study in Rheumatoid Arthritis
OSRA
1 other identifier
interventional
249
1 country
1
Brief 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.
- 3.To establish the relationship between achieving a given STO or combination of STOs and damage progression.
- 4.To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 23, 2007
CompletedFirst Posted
Study publicly available on registry
March 26, 2007
CompletedSeptember 5, 2008
September 1, 2008
March 23, 2007
September 4, 2008
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis
Sydney, Australia
Related Publications (1)
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.
PMID: 23118111DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J Edmonds
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 23, 2007
First Posted
March 26, 2007
Study Start
March 1, 2002
Last Updated
September 5, 2008
Record last verified: 2008-09