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/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00451971