Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001310156
Ethics application status
Approved
Date submitted
4/09/2019
Date registered
25/09/2019
Date last updated
27/04/2023
Date data sharing statement initially provided
25/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rheumatoid interstitial lung disease in Canterbury New Zealand
Scientific title
Rheumatoid interstitial lung disease in Canterbury New Zealand
Secondary ID [1] 299168 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid interstitial lung disease 314244 0
Rheumatoid arthritis 314245 0
Condition category
Condition code
Respiratory 312606 312606 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 312713 312713 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
Retrospective audit of medical records of persons aged 18 years of age and older in the region of the Canterbury District Health Board (CDHB), held at Canterbury District Health Board as well as private rheumatology providers in Canterbury, between 1/1/2006-31/12/2008 and between 1/1/2011–31/12/2013.
Intervention code [1] 315453 0
Diagnosis / Prognosis
Intervention code [2] 315540 0
Early Detection / Screening
Comparator / control treatment
Patients with RA-ILD will be compared with patients with RA without interstitial lung disease.
Control group
Active

Outcomes
Primary outcome [1] 321250 0
Incidence and prevalence of RA in Canterbury - assessed by audit of medical records
Timepoint [1] 321250 0
Two time periods: 1/1/2006-31/12/2008 and between 1/1/2011–31/12/2013 will be examined. The prevalence and incidence of RA for the two time periods will be calculated.
Primary outcome [2] 321251 0
Incidence and prevalence of RA-ILD - assessed by audit of medical records
Timepoint [2] 321251 0
Two time periods: 1/1/2006-31/12/2008 and between 1/1/2011–31/12/2013 will be examined. T he prevalence and incidence of RA-ILD for the two time periods will be calculated. Individuals identified with RA during these time periods will be followed until 30/6/2019 to identify the cumulative incidence of RA-ILD.
Secondary outcome [1] 374452 0
Demographic characteristics (age at RA diagnosis, sex, ethnicity), clinical characteristics (seropositivity for RF, anti-CCP, baseline CRP, radiographic erosions), and environmental exposures (smoking, others if enough information available) will be examined by audit of medical records.
Timepoint [1] 374452 0
Individuals will be followed from the date of diagnosis of RA/RA-ILD, until death, last entry in the health record or 30 June 2019
Secondary outcome [2] 374453 0
Survival, assessed by audit of medical records
Timepoint [2] 374453 0
Kaplan-Meier methods will be used to estimate mortality rates for patients with RA-ILD during follow-up. Mortality for people with RA and RA-ILD will also be compared with the general population of the CDHB and standardised mortality ratios will be determined.

Eligibility
Key inclusion criteria
Individuals will be classified as having RA if they meet the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (previously known as European League Against Rheumatism) Rheumatoid Arthritis Classification Criteria. Individuals will be classified as having probable or definite RA-ILD if they meet pre-specified criteria: Probable ILD: Chest radiograph/chest CT evidence of ILD AND Treating physician diagnosis of ILD, Definite ILD: Chest radiograph/chest CT consistent with ILD AND 1 of: Diagnosis of ILD by a respiratory physician OR Presence of 2 longitudinal CT studies documenting the persistence of a diffuse interstitial pulmonary process consistent with reported interstitial pneumonia patterns in RA OR Lung biopsy consistent with ILD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who do not meet the classification criteria for RA. Individuals who did not live in the region of the Canterbury District Health Board during the study periods.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The prevalence and incidence of RA and RA-ILD for the two time periods will be calculated using CDHB population data from the 2006 and 2013 New Zealand censuses. Prevalence and incidence rates will be age- and sex-adjusted to a standard population (e.g., US 2010) to facilitate comparisons with rates from other populations. Development of ILD among all people with RA will be determined by reviewing the clinical notes of patients with RA during longitudinal follow-up. The cumulative incidence of RA-ILD among patients with incident RA during each of the two time periods will be calculated. The association between the development of ILD and demographic characteristics (age at RA diagnosis, sex, ethnicity), clinical characteristics (seropositivity for RF, anti-CCP, CRP, radiographic erosions), and environmental exposures (smoking, others if enough information available) will be examined using Cox-proportional hazard models adjusting for age, sex, and smoking status. Hazard ratios and 95% confidence intervals for different risk factors will be calculated. Kaplan-Meier methods will be used to estimate mortality rates for patients with RA-ILD. Mortality for people with RA and RA-ILD will also be compared with the general population of the CDHB and standardised mortality ratios will be determined. Pulmonary function data will be collated to identify individuals in whom a clinically significant decline is found.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
30/06/2022
Actual
30/01/2023
Date of last data collection
Anticipated
22/09/2024
Actual
Sample size
Target
482181
Accrual to date
Final
1930
Recruitment outside Australia
Country [1] 21830 0
New Zealand
State/province [1] 21830 0
Canterbury

Funding & Sponsors
Funding source category [1] 303709 0
University
Name [1] 303709 0
University of Otago
Country [1] 303709 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago, Christcuhrch
PO Box 4345
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303943 0
None
Name [1] 303943 0
Address [1] 303943 0
Country [1] 303943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304235 0
University of Otago Human Research Ethics Committee
Ethics committee address [1] 304235 0
Ethics committee country [1] 304235 0
New Zealand
Date submitted for ethics approval [1] 304235 0
Approval date [1] 304235 0
22/08/2019
Ethics approval number [1] 304235 0
H18/079

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96230 0
Prof Lisa Stamp
Address 96230 0
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch
New Zealand
Country 96230 0
New Zealand
Phone 96230 0
+64 3 364 0530
Fax 96230 0
Email 96230 0
[email protected]
Contact person for public queries
Name 96231 0
Hamish Farquhar
Address 96231 0
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch
New Zealand
Country 96231 0
New Zealand
Phone 96231 0
+64 3 364 0530
Fax 96231 0
Email 96231 0
[email protected]
Contact person for scientific queries
Name 96232 0
Hamish Farquhar
Address 96232 0
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch
New Zealand
Country 96232 0
New Zealand
Phone 96232 0
+64 3 364 0530
Fax 96232 0
Email 96232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for this has not been obtained


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4504Study protocol    378293-(Uploaded-04-09-2019-11-06-48)-Study-related document.docx
15897Study protocol https://bmjopen.bmj.com/content/12/4/e050934.full 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRheumatoid interstitial lung disease in Canterbury New Zealand: Prevalence, risk factors and long-term outcomes - Protocol for a population-based retrospective study.2022https://dx.doi.org/10.1136/bmjopen-2021-050934
EmbaseRheumatoid interstitial lung disease in Canterbury, Aotearoa New Zealand - A retrospective cohort study.2024https://dx.doi.org/10.1016/j.semarthrit.2023.152359
N.B. These documents automatically identified may not have been verified by the study sponsor.