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/NCT00751387




Registration number
NCT00751387
Ethics application status
Date submitted
11/09/2008
Date registered
12/09/2008
Date last updated
30/11/2010

Titles & IDs
Public title
Study Evaluating Epidemiology of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in Australia
Scientific title
Australian Descriptive Epidemiology Study of Severity of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) and Exposure to Biological Disease Modifying Anti-rheumatic Drugs (bDMARDs)
Secondary ID [1] 0 0
B1801088
Secondary ID [2] 0 0
0881X1-4519
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Psoriatic Arthritis 0 0
Rheumatoid Arthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis patients in defined disease severity categories
Timepoint [1] 0 0
Single visit
Secondary outcome [1] 0 0
Proportion of patients exposed to biological disease modifying antirheumatic drugs
Timepoint [1] 0 0
Single visit

Eligibility
Key inclusion criteria
Inclusion criteria include:

Adult patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who have visited a primary care centre within one of the specified catchment areas for their condition within the last 24 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
559
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Georgetown
Recruitment hospital [2] 0 0
- Miranda
Recruitment hospital [3] 0 0
- Newcastle
Recruitment hospital [4] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
2298 - Georgetown
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment postcode(s) [3] 0 0
2300 - Newcastle
Recruitment postcode(s) [4] 0 0
2500 - Wollongong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is a cross sectional, epidemiology study of disease severity for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in Australia (Illawarra, Sutherland, Hunter Urban and Hunter Rural).
Trial website
https://clinicaltrials.gov/study/NCT00751387
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
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/study/NCT00751387