ANCHOR-RA Study
Research type
Research Study
Full title
A Prospective, Multi-national, Cross-sectional Study on a Risk-factor Guided Approach to Interstitial Lung Disease Screening in Patients with Rheumatoid Arthritis at Higher Risk for ILD Using High Resolution Computed Tomography
IRAS ID
304541
Contact name
Paul Emery
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The overall aim of the study is to develop and validate a rheumatoid arthritis
(RA) - interstitial lung disease (ILD) clinical prediction model (screening tool)
based on risk factors to guide screening for ILD in patients with RA using high
resolution computed tomography (HRCT).Primary objectives
1. To identify factors associated with the development of ILD and to
establish and validate a multivariable clinical prediction model for
identification of ILD in RA patients.
2. To establish clinical decision rules on the use of HRCT for screening for
ILD in RA patients that are associated with a high probability for ILD.
3. To characterize the prevalence and radiological features of ILD.Secondary objectives
1. To describe the disease characteristics (e.g., age at RA diagnosis,
duration of RA, forced vital capacity [FVC], diffusing capacity for
carbon monoxide [DLco]) of RA-ILD patients with and without
respiratory symptoms (cough and dyspnoea).
2. To compare the diagnostic accuracy of prediction models in
asymptomatic and symptomatic populations, respectively.
3. To compare the diagnostic accuracy of spirometry, DLco, and
respiratory examination to HRCT findings relevant to RA-ILD.Exploratory objectives
1. To assess the predictive performance of the model established in
primary analysis that additionally contains research biomarkers (e.g.,
Mucin 5B [MUC5B] promoter variant). If research biomarkers are
informative, clinical decision rules are to be established.
2. To assess the predictive performance of the model established in
primary analysis using endpoints definitions according to different
thresholds of ILD extension and various ILD patterns on HRCT.
3. To characterize the prevalence and radiological features of bronchiectasis.
4. To characterize the prevalence and radiological features of emphysema.
5. To compare the diagnostic accuracy of screening lung ultrasound to
HRCT (sub-study).REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0742
Date of REC Opinion
5 Sep 2023
REC opinion
Favourable Opinion