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

This study is currently recruiting participants.
Verified November 2011 by Optimus Clinical Research
Sponsor:
Collaborator:
Arthritis Australia, Abbott Australia
Information provided by (Responsible Party):
Paul Bird, Optimus Clinical Research
ClinicalTrials.gov Identifier:
NCT01482507
First received: November 27, 2011
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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).


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Optimus Clinical Research:

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Newly diagnosed Patients with active Rheumatoid Arthritis

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482507

Locations
Australia, New South Wales
Optimus Clinical Research Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Wendy Gellatley     61 2 95870238     wgellatley@optimusresearch.com.au    
Principal Investigator: Paul Bird, Dr            
Sponsors and Collaborators
Optimus Clinical Research
Arthritis Australia, Abbott Australia
Investigators
Principal Investigator: Paul Bird, Dr Optimus Clinical Research
  More Information

No publications provided

Responsible Party: Paul Bird, Principal Investigator, Optimus Clinical Research
ClinicalTrials.gov Identifier: NCT01482507     History of Changes
Other Study ID Numbers: IMM 10-0120 (DWI101)
Study First Received: November 27, 2011
Last Updated: November 29, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013