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

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Optimus Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newly diagnosed Patients with active Rheumatoid Arthritis

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Optimus Clinical Research
• Collaborators: Arthritis Australia, Abbott Australia
• Investigators: Principal Investigator: Paul Bird, Dr, Optimus Clinical Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2011
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: November 27, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (ESTIMATE): November 30, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IMM 10-0120 (DWI101)