Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00451971




Registration number
NCT00451971
Ethics application status
Date submitted
23/03/2007
Date registered
26/03/2007
Date last updated
5/09/2008

Titles & IDs
Public title
Objective Study in Rheumatoid Arthritis
Scientific title
Objective Study in Rheumatoid Arthritis
Secondary ID [1] 0 0
HWA486_4020
Universal Trial Number (UTN)
Trial acronym
OSRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LEFLUNOMIDE

Treatment: Drugs: LEFLUNOMIDE
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
Timepoint [1] 0 0
Primary outcome [2] 0 0
The Short Term Objectives are: swollen joint count - target:(28) = 2 joints
Timepoint [2] 0 0
Primary outcome [3] 0 0
C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00451971
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
J Edmonds
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00451971