Examination of the Effectiveness of Diffusion Weighted Ma... | NCT01482507

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

NCT01482507

Sponsor

Optimus Clinical Research

Status

Completed

Last Update Posted

Apr 6, 2018Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 27, 2011

First Submission Date that Met QC Criteria

Nov 29, 2011

First Posted Date

Nov 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 6, 2018Actual

Name	Class
Arthritis Australia, Abbott Australia	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Newly diagnosed Patients with active Rheumatoid Arthritis

Sampling Method

Probability Sample

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases