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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482507
• Other study ID #: IMM 10-0120 (DWI101)
• Status: Completed
• First received: November 27, 2011
• Last updated: April 4, 2018
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2011
• Source: Optimus Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Australia	Optimus Clinical Research	Kogarah	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Optimus Clinical Research	Arthritis Australia, Abbott Australia

Country where clinical trial is conducted

Australia,