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Trial registered on ANZCTR


Registration number
ACTRN12613000938707
Ethics application status
Approved
Date submitted
21/08/2013
Date registered
26/08/2013
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results information initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Predicting response to biologics in rheumatoid arthritis
Scientific title
Predicting response to biologics in rheumatoid arthritis
Secondary ID [1] 283048 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 289885 0
Condition category
Condition code
Inflammatory and Immune System 290250 290250 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study. Patients receiving bioloigic therapy for treatment of rheumatoid arthritis will be recruited. Patients will be seen prior to treatment and at 4-6 months after commencing treatment. Disease activity will be assessed using standard measures including swollen joint count, tender joint count, C reactive protein and the composite disease acitivty score 28.
Intervention code [1] 287766 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290267 0
Response to biologic as determined by disease activity score
Timepoint [1] 290267 0
4 months
Secondary outcome [1] 304224 0
Change in inflammatory cytokines measured in the serum
Timepoint [1] 304224 0
4 months
Secondary outcome [2] 304283 0
Change in gene expression in peripheral blood cells measured by quantitative polymerase chain reaction
Timepoint [2] 304283 0
4 months

Eligibility
Key inclusion criteria
Patients with rheumatoid arthritis as defined by American College of Rheumatology Criteria whom the treating clinician has started biological therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to provide informed consent

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5322 0
New Zealand
State/province [1] 5322 0
Christchurch
Country [2] 5323 0
New Zealand
State/province [2] 5323 0
Dunedin

Funding & Sponsors
Funding source category [1] 287812 0
Government body
Name [1] 287812 0
Health Research Council of New Zealand
Address [1] 287812 0
PO Box 5541,
Wellesley Street,
Auckland 1141
Country [1] 287812 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
P.O.Box 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 286541 0
None
Name [1] 286541 0
Address [1] 286541 0
Country [1] 286541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289762 0
University of Otago Ethics Committee
Ethics committee address [1] 289762 0
P.O.Box 56
Dunedin 9054
Ethics committee country [1] 289762 0
New Zealand
Date submitted for ethics approval [1] 289762 0
Approval date [1] 289762 0
02/08/2013
Ethics approval number [1] 289762 0
13/040

Summary
Brief summary
The introduction of “biological” disease modifying anti-rheumatic drugs (bDMARDs) has been a major advance in the treatment of rheumatoid arthritis (RA). When conventional therapy fails, bDMARD therapy can be life changing. bDMARDs specifically target key components in the pathways of inflammation causing RA, such as the pro-inflammatory cytokine tumour necrosis factor-a (TNF). Consequently, knowledge of the inflammatory pathways active in individual patients is required for efficient targeting of bDMARDs. We have established a classification of joint synovial tissues, based on the expression of interleukin (IL) 17-A and CD21L genes, reflecting different inflammatory states. Our objective is to determine if we can predict response to anti-TNF therapy based on this system and concentrations of IL-17-related cytokines. The ability to predict response to treatment will improve outcomes for patients with RA and provide cost savings by ensuring that those patients most likely to respond receive these highly effective but expensive drugs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42286 0
Prof Lisa Stamp
Address 42286 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 42286 0
New Zealand
Phone 42286 0
+6433640953
Fax 42286 0
Email 42286 0
lisa.stamp@cdhb.govt.nz
Contact person for public queries
Name 42287 0
Prof Lisa Stamp
Address 42287 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 42287 0
New Zealand
Phone 42287 0
+6433640953
Fax 42287 0
Email 42287 0
lisa.stamp@cdhb.govt.nz
Contact person for scientific queries
Name 42288 0
Prof Lisa Stamp
Address 42288 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 42288 0
New Zealand
Phone 42288 0
+6433640953
Fax 42288 0
Email 42288 0
lisa.stamp@cdhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 193 0
Conference abstract
Citation/DOI/link/details [1] 193 0
Fanning et al American College of Rheumatology Annual Scientific Meeting Chicago USA October 2018
Attachments [1] 193 0
Results – basic reporting
Results – plain English summary