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Trial registered on ANZCTR


Registration number
ACTRN12613000123741
Ethics application status
Approved
Date submitted
30/01/2013
Date registered
1/02/2013
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Response to biologics in rheumatoid arthritis
Scientific title
Response to biologics in rheumatoid arthriits to determine the relationship between antidrug antibodies, drug concentrations and disease activity.
Secondary ID [1] 281867 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rheumatoid arthritis 288248 0
Condition category
Condition code
Inflammatory and Immune System 288602 288602 0 0
Rheumatoid arthritis

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. Disease activity will be observed before and 6 months after starting biological therapy. The biological therapy used will be determined by the treating physician on a case by case basis. There will be one observation immediately prior to starting biological therapy. Duration of therapy will be determined by the treating physician depending on response, tolerability and adverse effects
Intervention code [1] 286429 0
Not applicable
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288752 0
Relationship between antidrug antibodies and disease activity. Disease activity will be assessed examination to determine using swollen and tender joint counts, calculation of disease activity score, and laboratory measurement of c reactive protein
Timepoint [1] 288752 0
A single timepoint between 4 and 6 months after starting biological therapy
Primary outcome [2] 288753 0
Relationship between disease activity and drug concentrations.Disease activity will be assessed examination to determine using swollen and tender joint counts, calculation of disease activity score, and laboratory measurement of c reactive protein
Timepoint [2] 288753 0
A single timepoint between 4 and 6 months after starting biological therapy
Secondary outcome [1] 300906 0
nil
Timepoint [1] 300906 0
nil

Eligibility
Key inclusion criteria
I.Male or female, aged >/=18 years, with Rheumatoid Arthritis as defined by the ACR Criteria (Aletaha et al. 2010) receiving or commencing any biologic therapy.
II.Able and willing to give written informed consent and to comply with the requirements of the study.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with serious uncontrolled chronic concomitant disease

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
recruited from another study
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] 4828 0
New Zealand
State/province [1] 4828 0
Christchurch

Funding & Sponsors
Funding source category [1] 286644 0
Charities/Societies/Foundations
Name [1] 286644 0
Arthritis New Zealand
Address [1] 286644 0
P.O. Box 10020
Wellington 6011
Country [1] 286644 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] 285427 0
None
Name [1] 285427 0
Address [1] 285427 0
Country [1] 285427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288720 0
University of Otago Human Ethics Committee
Ethics committee address [1] 288720 0
P.O.Box 56
Dunedin 9054
Ethics committee country [1] 288720 0
New Zealand
Date submitted for ethics approval [1] 288720 0
01/02/2013
Approval date [1] 288720 0
04/03/2013
Ethics approval number [1] 288720 0
13/040

Summary
Brief summary
Rheumatoid arthritis (RA) is a common condition affecting 1-2% of the population. Early intensive treatment that effectively suppresses the disease is required to prevent irreversible joint damage. Many patients require the newer expensive biologic therapies, access to which is determined by PHARMAC rules. However it is not possible to predict which patients will respond to treatment. Furthermore, patients receive the same dose regimen, which does not allow for differences between patients in how the drug is cleared from the body. Measuring concentrations of drug in the blood may allow better patient outcomes by adjusting the dose regimen. Furthermore, some patients receiving biological therapies may develop antibodies against the drug. The effect of these antibodies on blood concentrations of the drug, or response to the drug or subsequent treatments, is not well established. This study aims to address these issues by measuring drug concentrations and anti-drug antibodies and relating these to treatment effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37478 0
Prof Lisa Stamp
Address 37478 0
Department of Medicine
University of Otago, Chirstchurch
P.O.Box 4345
Christchurch 8014
Country 37478 0
New Zealand
Phone 37478 0
+6433640953
Fax 37478 0
Email 37478 0
lisa.stamp@cdhb.health.nz
Contact person for public queries
Name 37479 0
Ms Janine Francis
Address 37479 0
Department of Medicine
University of Otago, Chirstchurch
P.O.Box 4345
Christchurch 8014
Country 37479 0
New Zealand
Phone 37479 0
+6433786487
Fax 37479 0
Email 37479 0
janine.francis@cdhb.health.nz
Contact person for scientific queries
Name 37480 0
Prof Lisa Stamp
Address 37480 0
Department of Medicine
University of Otago, Chirstchurch
P.O.Box 4345
Christchurch 8014
Country 37480 0
New Zealand
Phone 37480 0
+6433640953
Fax 37480 0
Email 37480 0
lisa.stamp@cdhb.health.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?
No
Results – basic reporting
Results – plain English summary