Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001011279
Ethics application status
Approved
Date submitted
30/01/2009
Date registered
23/11/2009
Date last updated
13/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The burden of subclinical synovial inflammation in gout
Scientific title
An observational pilot study to assess the burden of subclinical synovial inflammation in gout
Secondary ID [1] 1142 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 4255 0
Condition category
Condition code
Musculoskeletal 4477 4477 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Routine drug therapy as perscribed by the treating physician. This may include agents to treat acute gout including Non steroidal anti inflammatory drugs, colchicine and corticosteroids, and prophylactic agents including allopurinol and probenicid. Each Participant will be observed at two time points, once during acute gout and onbce during intercritical gout. The timing of observation will depend on the natural history of the disease in each patient, however it would be presumed that both observations would occur within a 12 month period. Patients will be reassessed at 2 years with repeat radiographs of joints imaged at baseline ( for clincal reasons) to look for progression of damage
Intervention code [1] 3977 0
Treatment: Drugs
Comparator / control treatment
Not applicable as this is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5357 0
Ultrasound detected synovitis
Timepoint [1] 5357 0
The primary outcome will be determined when the study subject has completed 2 study visits. These will be one visit during an intercritical period and one visit during a critical period of gout. The timepoints at which outcomes will be assessed depends on the clincial status of the patients, will be variable and cannot be specified a-priori, however we envisage all patients will complete alla ssessments within a 12 month period from enrolment in the study.
Primary outcome [2] 287741 0
Samples of serum and urine will be analysed for appropriate biomarkers of synovial inflammation, including hylauronan, C telopeptide of type 11 collagen, and RAGE using ELISA kits
Timepoint [2] 287741 0
The primary outcome will be determined when the study subject has completed 2 study visits. These will be one visit during an intercritical period and one visit during a critical period of gout. The timepoints at which outcomes will be assessed depends on the clincial status of the patients, will be variable and cannot be specified a-priori, however we envisage all patients will complete alla ssessments within a 12 month period from enrolment in the study
Secondary outcome [1] 298754 0
The relationship between synovial inflammation detected at baseline and progression of Xray changes at 2 years
Timepoint [1] 298754 0
2 years

Eligibility
Key inclusion criteria
1. A diagnosis of gout based on clinical presentation ( history, examination and biochemical tests)
2. Ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Inability to give informed consent
2.Contraindication or unwillingness to undergo an ultrasound scan
3.Diagnosis of other inflammatory joint disorder, such as rheumatoid arthritis

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4434 0
University
Name [1] 4434 0
University of Western Australia
Country [1] 4434 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street
Perth,
Western Australia,
6000.
Country
Australia
Secondary sponsor category [1] 3995 0
None
Name [1] 3995 0
Address [1] 3995 0
Country [1] 3995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6486 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 6486 0
Ethics committee country [1] 6486 0
Date submitted for ethics approval [1] 6486 0
04/02/2009
Approval date [1] 6486 0
21/05/2009
Ethics approval number [1] 6486 0
EC 2009/020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29235 0
Address 29235 0
Country 29235 0
Phone 29235 0
Fax 29235 0
Email 29235 0
Contact person for public queries
Name 12482 0
Dr Priya Chowalloor
Address 12482 0
Rheumatology Department
Royal Perth Hospital,
Wellington Street
Perth,
Western Australia,
6000
Country 12482 0
Australia
Phone 12482 0
+61 8 9224 2244
Fax 12482 0
Email 12482 0
[email protected]
Contact person for scientific queries
Name 3410 0
Helen Keen
Address 3410 0
Rheumatology Department
Royal Perth Hospital,
Wellington Street
Perth,
Western Australia,
6000
Country 3410 0
Australia
Phone 3410 0
+61 8 9224 2244
Fax 3410 0
Email 3410 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.