Rheumatoid ArthritisNCT01482507
Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Optimus Clinical Research at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed Patients with active Rheumatoid Arthritis
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Permanent Pacemaker
- Intracerebral aneurysm clip
- Claustrophobia to the extent that patient cannot manage MRI investigations
- Implanted metallic device
- Cochlear implant
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimus Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Australia, Abbott Australia
- Responsible party
- Principal investigator, Paul Bird, Optimus Clinical Research
- Investigators
- Paul Bird, Dr, Principal investigator, Optimus Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482507
- Sponsor's protocol ID
- IMM 10-0120 (DWI101)
- Status last verified
- Nov 2011
- First submitted
- 27 Nov 2011
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01482507
- Acronym / sponsor ID
- IMM 10-0120 (DWI101)
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Optimus Clinical ResearchUniversity, hospital or other
- Collaborators
- Arthritis Australia, Abbott Australia
- Study start
- Aug 2011 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed Patients with active Rheumatoid Arthritis
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Bird, Dr principal investigator
Optimus Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Optimus Clinical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.