Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis

NCT ID: NCT01482507

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-12-31

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).

Detailed Description

Assess DWI MRI in patients with early Rheumatoid Arthritis to determine whether the MRI method will assist in differentiating poor prognosis bone oedema more effectively than traditional T2 weighted MRI.

Aim 1: To compare DWI MRI with T2 weighted MRI for the discrimination of different types of bone oedema lesions in patients with early RA.

Aim 2: To examine the association between the presence of different types of bone oedema lesions detected on DWI MRI and T2 weighted MRI and the development of subsequent joint bone erosion as detected on i) MRI and ii) standard plain radiographs.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthritis Australia, Abbott Australia

UNKNOWN

Sponsor Role: collaborator

Optimus Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Paul Bird

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Bird, Dr

Role: PRINCIPAL_INVESTIGATOR

Optimus Clinical Research

Locations

Optimus Clinical Research

Kogarah, New South Wales, Australia

Countries

Australia

Other Identifiers

IMM 10-0120 (DWI101)

Identifier Type: -

Identifier Source: org_study_id