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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/NCT01482507




Registration number
NCT01482507
Ethics application status
Date submitted
27/11/2011
Date registered
30/11/2011
Date last updated
6/04/2018

Titles & IDs
Public title
Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis
Scientific title
Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
IMM 10-0120 (DWI101)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Subject has Rheumatoid Arthritis as defined by the ACR/Eular criteria

- Subject is able to understand and comply with study protocol

- Active disease as defined by DAS28> 3.0

- Disease duration less than 12 months

- If female, subject is either not of childbearing potential, or is of childbearing
potential and is practicing an approved method of birth control throughout the study

- subject is judged to be in good health as determined by the PI based upon results of
medical history, laboratory profile and physical examination.

- Prednisone dose 10mg or less, dose stable for 28 days prior to baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inflammatory arthropathy other than Rheumatoid Arthritis

- Inactive disease as evidenced by DAS 28 CRP and / or ESR < 2.5

- Prednisone dose greater than 10mg within 28 days prior to baseline

- Intra-articular steroid within 28 days prior to baseline visit

- IV Methyl-prednisone within 28 days prior to baseline visit

- Any contra-indication to Magnetic Resonance Imaging

- Permanent Pacemaker

- Intracerebral aneurysm clip

- Claustrophobia to the extent that patient cannot manage MRI investigations

- Implanted metallic device

- Cochlear implant

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Optimus Clinical Research - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

Funding & Sponsors
Primary sponsor type
Other
Name
Optimus Clinical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Arthritis Australia, Abbott Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Diffusion Weighted Imaging (DWI) MRI will assist in differentiating poor prognosis bone
oedema more effectively than traditional T2 weighted MRI in patients with early Rheumatoid
Arthritis (RA).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01482507
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Bird, Dr
Address 0 0
Optimus Clinical Research
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