Trial Review

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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.
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.
Secondary ID [1] 281049 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 287190 0
Condition category
Condition code
Musculoskeletal 287519 287519 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 285509 0
Not applicable
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
Control group
Active

Outcomes
Primary outcome [1] 287763 0
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.
Timepoint [1] 287763 0
Study duration is 18 months. Assessment every 3 months.

Total of 7 study visits over 18 months.
Secondary outcome [1] 298795 0
To correlate baseline MRI features with subsequent radiological progression as assessed by plain radiographs.
Timepoint [1] 298795 0
Screen Visit and Final Study Visit

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285847 0
Commercial sector/Industry
Name [1] 285847 0
Abbott Australasia Pty Ltd
Country [1] 285847 0
Australia
Primary sponsor type
Other
Name
Emeritus Research
Address
291 Wattletree Road
Malvern East Victoria 3145
Country
Australia
Secondary sponsor category [1] 284669 0
None
Name [1] 284669 0
Address [1] 284669 0
Country [1] 284669 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287855 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 287855 0
183 Wattletree Road
Malvern Victoria 3144
Ethics committee country [1] 287855 0
Australia
Date submitted for ethics approval [1] 287855 0
Approval date [1] 287855 0
31/01/2012
Ethics approval number [1] 287855 0
14-05-12-11

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34589 0
Address 34589 0
Country 34589 0
Phone 34589 0
Fax 34589 0
Email 34589 0
Contact person for public queries
Name 17836 0
Stephen Hall
Address 17836 0
Emeritus Research
291 Wattletree Road
Malvern East, Victoria 3145
Country 17836 0
Australia
Phone 17836 0
+613 9509 6166
Fax 17836 0
Email 17836 0
stephenhall@emeritusresearch.com
Contact person for scientific queries
Name 8764 0
Stephen Hall
Address 8764 0
Emeritus Research
291 Wattletree Road
Malvern East, Victoria 3145
Country 8764 0
Australia
Phone 8764 0
+613 9509 6166
Fax 8764 0
+613 9509 2229
Email 8764 0
stephenhall@emeritusresearch.com

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
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