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Trial registered on ANZCTR
Registration number
ACTRN12612000903886
Ethics application status
Approved
Date submitted
17/08/2012
Date registered
24/08/2012
Date last updated
24/08/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) and radiological study of Rheumatoid Arthritis treated with Adalimumab and non-biological agents to assess the impact of disease control on MRI manifestations and joint structure preservation.
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Scientific title
Magnetic Resonance Imaging (MRI) and radiological study of Rheumatoid Arthritis treated with Adalimumab and non-biological agents to assess the impact of disease control on MRI manifestations and joint structure preservation.
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Secondary ID [1]
281049
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
287519
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is an observational study looking at disease control and joint structure preservation in people with Rheumatoid Arthritis treated with non-biologic agents and Adalimumab. This involves a descriptive comparism of MRI features using RAMRIS scores in participants with varying degrees of disease control taking adalimumab and conventional DMARD therapy in a cross sectional analysis. A second longitudinal analysis will be performed assessing plain radiographs of hands and feet with a conventional radiological scoring system and correlated with the baseline MRI appearances. There are 7 study visits over an 18 months period.
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Intervention code [1]
285509
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Not applicable
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Comparator / control treatment
This is an observational study looking at disease control and joint preservation in Rheumatoid Arthritis patients who are being treated with either a non-biological agent or a biological agent known as Adalimumab
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Control group
Active
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Outcomes
Primary outcome [1]
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To assess the impact of disease control on MRI manifestations and joint structure preservation in Rheumaotid Arthritis (RA) patients treated with Adalimumab and non-biological agents.
This involves a descriptive comparism of MRI features using RAMRIS scores in participants with varying degrees of disease control taking adalimumab and conventional DMARD therapy in a cross sectional analysis. A second longitudinal analysis will be performed assessing plain radiographs of hands and feet with a conventional radiological scoring system and correlated with the baseline MRI appearances. Clincial assessments ae scheduled every 3 months. Routine blood samples will be analysed including inflammatory markers. A joint assessment will be performed and patient assessment of disease activity recorded in order to calculate the DAS28 score. This score is used as a measure of disease activity. There are 7 study visits over an 18 months period.
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Assessment method [1]
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Timepoint [1]
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Study duration is 18 months. Assessment every 3 months.
Total of 7 study visits over 18 months.
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Secondary outcome [1]
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To correlate baseline MRI features with subsequent radiological progression as assessed by plain radiographs.
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Assessment method [1]
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Timepoint [1]
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Screen Visit and Final Study Visit
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Eligibility
Key inclusion criteria
1. Stable therapy for at least 6 months, non-biological DMARDs with a DAS-28 of < 2.6
2. Stable therapy for at least six months, Adalimumab, DAS-28 < 2.6.
3. Stable therapy for at least six months, Adalimumab, DAS -28 > 3.2
4. Rheumatoid factor or CCP positive at some stage in the course of their disease
5. Capable of undergoing MRI examinations.
6. Capable of understanding the Informed Consent document.
7. Anticipate stable treatment for at least 18 months
8. Reliable to attend for the review
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Contra-indications to MRI examination, including but not limited, to metallic brain clips, previous stapedectomy, cardiac pacemaker, profound claustrophobia or inability to lie in the MRI machine in an appropriate position to obtain quality images.
2. Women who are pregnant or breast feeding or planning to become pregnant during the study.
3. Treatment with any investigational therapy within 3 months
4. Not willing to return for required follow-up visits or there is a clear demonstration of likely poor compliance;
5. Any other medical condition (including current infections) that, in the judgment of the Investigator, would prohibit the patient from participating in the study.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Abbott Australasia Pty Ltd
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Address [1]
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32-34 Lord St
Botany NSW 2019
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Emeritus Research
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Address
291 Wattletree Road
Malvern East Victoria 3145
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
284669
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Address [1]
284669
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Country [1]
284669
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Cabrini Human Research Ethics Committee
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Ethics committee address [1]
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183 Wattletree Road
Malvern Victoria 3144
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
287855
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Approval date [1]
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31/01/2012
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Ethics approval number [1]
287855
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14-05-12-11
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Summary
Brief summary
Rheumatoid Arthritis (RA) is a chronic disease which when left untreated leads to long term joint damage, loss of function and a reduced life expectancy. There is evidence that by treating RA early with combination therapies the damage to the joints may be much less and function preserved. Following on from this observation, many rheumatologists think aiming for a specific end point to prevent progressive joint damage should be introduced. However, new TNF agents such as Adalimumab seem to protect against damage more than do conventional therapies even when signs and symptoms of arthritis are equally controlled. The explanation for this is unclear and needs to be explored further.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Stephen Hall
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Address
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Emeritus Research
291 Wattletree Road
Malvern East, Victoria 3145
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Country
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Australia
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Phone
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+613 9509 6166
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Stephen Hall
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Address
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Emeritus Research
291 Wattletree Road
Malvern East, Victoria 3145
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Country
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Australia
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Phone
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+613 9509 6166
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Fax
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+613 9509 2229
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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