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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Objective Study in Rheumatoid Arthritis
Scientific title
Objective Study in Rheumatoid Arthritis
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
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
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

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

Treatment: Drugs: LEFLUNOMIDE

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

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

Key inclusion criteria
- Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and

- 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
Both males and females
Can healthy volunteers participate?
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
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 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
J Edmonds
Address 0 0
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
Other publications