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Trial registered on ANZCTR


Registration number
ACTRN12614000895684
Ethics application status
Approved
Date submitted
1/08/2014
Date registered
22/08/2014
Date last updated
30/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnetic resonance Imaging (MRI) inflammation as an imaging biomarker in rheumatoid arthritis: monitoring response to the “Treat to Target” approach
Scientific title
MRI inflammation as an imaging biomarker in rheumatoid arthritis: comparing the change in MRI-inflammation scores between patients receiving treatment for disease flare with combination conventional disease suppressing therapy and those commencing combination methotrexate/anti-tumour necrosis factor (TNF) therapy
Secondary ID [1] 285091 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rheumatoid arthritis 292636 0
Condition category
Condition code
Inflammatory and Immune System 292950 292950 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
The aim of this study is to obtain MRI inflammation scores (osteitis, synovitis, tenosynovitis) before and 3 months after a change in drug therapy for treatment of rheumatoid arthritis. We will explore whether changes in MRI scores mirror changes in clinical measures of disease activity that occur over this time period.
As this is an observational study there will be no intervention designated by the researchers.
Instead, clinicians treating rheumatoid arthritis patients will choose the appropriate therapy on clinical grounds.
We aim to use observational data to compare MRI responses in 2 groups of patients.
1) Patients who have had an inadequate response to methotrexate alone and are about to be escalated to combination conventional disease modifying antirheumatic drug (DMARD) therapy.
2) patients who have had an inadequate response to conventional combination DMARD therapy and are being escalated to methotrexate/anti-TNF therapy.
Intervention code [1] 289938 0
Not applicable
Comparator / control treatment
2) patients who have had an inadequate response to conventional combination DMARD therapy and are being escalated to methotrexate/anti-TNF therapy.

The overall duration of observation in each participant, will be 2 years
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292810 0
Change in MRI inflammation score including scores for synovitis, osteitis and tenosynovitis. These will be assessed by the OMERACT RA-MRI scoring system (RAMRIS) and the tenosynovitis score will be assessed according to the method described by Haarvardsholm et al.Annals of the Rheumatic Diseases, 2007. 66(9): p. 1216-20.
Timepoint [1] 292810 0
Scores will be assessed at baseline and then 3 months after the change in therapy
Secondary outcome [1] 309716 0
Change in Disease activity score (DAS) 28CRP SF-36
Timepoint [1] 309716 0
3 months
Secondary outcome [2] 309718 0
change in 66 swollen joint counts,
Timepoint [2] 309718 0
3 months
Secondary outcome [3] 309806 0
change in 68 tender joint count
Timepoint [3] 309806 0
3 months
Secondary outcome [4] 309807 0
change in visual analogue pain score (100mm)
Timepoint [4] 309807 0
3 months
Secondary outcome [5] 309808 0
change in visual analogue general health score (patient)
Timepoint [5] 309808 0
3 months
Secondary outcome [6] 309809 0
change in Health Assessment Questionnaire (HAQ) score,
Timepoint [6] 309809 0
3 months
Secondary outcome [7] 309810 0
change in Sharp van der Heijde joint damage score
Timepoint [7] 309810 0
2 years
Secondary outcome [8] 309811 0
change in CRP (measured using serum assay).
Timepoint [8] 309811 0
3 months

Eligibility
Key inclusion criteria
seropositive rheumatoid arthritis
Willing and eligible for disease modifying therapy including methotrexate, combination DAMRDS and /or anti-TNF therapy as per treating clinician's decision
Willing and eligible to have 2 contrast-enhanced MRI scans (no contraindications)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to the medical therapies for rheumatoid arthritis as outlined above
Patients will be excluded if there are contraindications to MRI scanning (obesity, claustrophobia, internal metalware) or have impaired renal function and cannot be given IV gadolinium (creatinine clearance must be > 60ml/min).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Group A was originally to be those on methotrexate alone and escalating to triple therapy (methotrexate, sulphasalazine, hydroxychloroquine) because of disease activity. This group has now been enlarged to include RA patients on any conventional DMARD combination whose disease is inadequately controlled and are therefore being escalated to a different cDMARD combination

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
20/10/2014
Date of last participant enrolment
Anticipated
20/04/2016
Actual
1/08/2016
Date of last data collection
Anticipated
8/12/2016
Actual
Sample size
Target
100
Accrual to date
Final
84
Recruitment outside Australia
Country [1] 6267 0
New Zealand
State/province [1] 6267 0

Funding & Sponsors
Funding source category [1] 289698 0
Charities/Societies/Foundations
Name [1] 289698 0
Auckland Medical Research Foundation
Country [1] 289698 0
New Zealand
Funding source category [2] 289730 0
Charities/Societies/Foundations
Name [2] 289730 0
Arthritis New Zealand
Country [2] 289730 0
New Zealand
Primary sponsor type
Individual
Name
Prof Fiona McQueen
Address
Dept of Molecular Medicine and Pathology
Rm 502-301B
Faculty of Medicine and Haelth Sciences
University of Auckland 85 Park Rd
Grafton Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 288391 0
University
Name [1] 288391 0
University of Auckland
Address [1] 288391 0
85 Park Rd
Grafton
Auckland 1023, NZ
Country [1] 288391 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291438 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 291438 0
Novotel Ellerslie, 72-112 Greenlane Rd East, Ellerslie, Auckland 1051
Ethics committee country [1] 291438 0
New Zealand
Date submitted for ethics approval [1] 291438 0
25/07/2014
Approval date [1] 291438 0
13/08/2014
Ethics approval number [1] 291438 0

Summary
Brief summary
Many new drug therapies are available for patients with rheumatoid arthritis (RA) but we need to know how effective they are. Currently, the patient’s response is assessed by counting swollen and tender joints, obtaining blood tests that reveal inflammation and combining these into a “Disease Activity Score” (DAS). In NZ we have internationally-recognised expertise in magnetic resonance imaging (MRI); a powerful tool for measuring arthritis activity. An “MRI-inflammation score (MRI-i)” can be obtained and may indicate persistent arthritis activity despite clinically normal joints. It is important to detect this subclinical arthritis activity as it can lead to long-term joint damage. This project draws on our team’s expertise in MRI and compares it with the current clinical gold standard for assessing arthritis activity. It is consistent with the Arthritis New Zealand aim “to restore joint structure and function” as detecting low-grade inflammation may trigger a treatment change, thus avoiding joint damage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50214 0
Prof Fiona McQueen
Address 50214 0
Dept of Molecular Medicine and Pathology
Faculty of Medicine and Health Sciences
University of Auckland
85 Park Rd
Grafton, Auckland 1023
New Zealand
Country 50214 0
New Zealand
Phone 50214 0
6421938610
Fax 50214 0
6493754324
Email 50214 0
[email protected]
Contact person for public queries
Name 50215 0
Fiona McQueen
Address 50215 0
Dept of Molecular Medicine and Pathology
Faculty of Medicine and Health Sciences
University of Auckland
85 Park Rd
Grafton, Auckland 1023
New Zealand
Country 50215 0
New Zealand
Phone 50215 0
6493797440
Fax 50215 0
Email 50215 0
[email protected]
Contact person for scientific queries
Name 50216 0
Karen Lindsay
Address 50216 0
Dept of Immunology
Auckland District Health Board
2 Park Road
Grafton, Auckland 1023
Country 50216 0
New Zealand
Phone 50216 0
6493670000
Fax 50216 0
Email 50216 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseChanges in clinical disease activity are weakly linked to changes in MRI inflammation on treat-to-target escalation of therapy in rheumatoid arthritis.2017https://dx.doi.org/10.1186/s13075-017-1433-7
N.B. These documents automatically identified may not have been verified by the study sponsor.