NCT01482507

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 6, 2018

Status Verified

November 1, 2011

Enrollment Period

3.3 years

First QC Date

November 27, 2011

Last Update Submit

April 4, 2018

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Newly diagnosed Patients with active Rheumatoid Arthritis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimus Clinical Research

Kogarah, New South Wales, 2217, Australia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paul Bird, Dr

    Optimus Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2011

First Posted

November 30, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 6, 2018

Record last verified: 2011-11

Locations

AU(1)