Factors of ILD in Newly Diagnosed Rheumatoid Arthritis
FIND-RA
2 other identifiers
interventional
300
1 country
2
Brief Summary
To determine factors associated with early RA-ILD (which may be asymptomatic). It is planned to recruit all patients with a newly diagnosed RA (symptoms since less than 3 years). In this study, all relevant demographic and clinical data will be collected. All patients will undergo lung function tests and high-resolution CT-scan of the lungs. Blood sample will be collected for measurement of (1) anti-CCP and rheumatoid factor measurement (good clinical practice) and a specific sample for the detection of the MUC5 promoter variant rs35705950. Our aim is thus to identify determinants of RA-ILD in the following population:
- Adults aged 18 to 90 years-old
- Diagnosis of rheumatoid arthritis (RA) based on ACR-EULAR 2010 criteria
- Onset of disease duration at least 1 year and at most 10 years prior to inclusion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Nov 2019
Typical duration for not_applicable rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 9, 2022
May 1, 2022
3.2 years
June 12, 2019
May 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of an interstitial lung disease
Detection of an interstitial lung disease associated with RA. We define RA-ILD by the presence of reticulations, ground-glass opacity and/or honeycombing at HRCT not explained by another cause (i.e. cardiac disease, infection or neoplasia).
from enrollment of patient to 3 months post enrollment
Secondary Outcomes (5)
Proportion of different ILD subtypes
from enrollment of patient to 3 months post enrollment
Proportion of patients presenting with a non-ILD lung involvement of RA
from enrollment of patient to 3 months post enrollment
rs35705950 variant of the MUC5B promoter
from enrollment of patient to 3 months post enrollment
anti-CCP antibodies
from enrollment of patient to 3 months post enrollment
relevant exposure
from enrollment of patient to 3 months post enrollment
Study Arms (1)
New RA patients
OTHER* Adults aged 18 to 90 years-old * Diagnosis of rheumatoid arthritis (RA) based on ACR-EULAR 2010 criteria * Onset of disease duration at least 1 year and at most 10 years prior to inclusion
Interventions
1. Lung function tests (standard of care) 1. Dynamic and static volumes (FVC, FEV1, TPC, RV) 2. Lung diffusion capacity for CO (DLCO) 2. Chest Xrays 3. High resolution CT scanner (HRCT)
Eligibility Criteria
You may qualify if:
- Adults aged 18 to 90 years-old
- Diagnosis of rheumatoid arthritis (RA) based on ACR-EULAR 2010 criteria
You may not qualify if:
- Pregnancy
- Inability to provide informed consent
- Inability to perform lung function tests or to comply with the protocol
- Active pulmonary infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
CHU-UCL Namur - Site Mont-Godinne
Yvoir, 5530, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antoine Froidure, MD PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- PRINCIPAL INVESTIGATOR
Patrick Durez, MD PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- PRINCIPAL INVESTIGATOR
Benoît Ghaye, MD PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All statistical analysis, including power calculation, will be performed in collaboration with the "Plate-forme en méthodologie statistique" of the UCLouvain. Pre-study estimations revealed that a sample size of 289 patients produces a two-sided 95% confidence interval with a precision (half-width) of 0,04 when the actual proportion is near 0,14.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2019
First Posted
July 1, 2019
Study Start
November 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
We will ensure study data confidentiality and anonymization (Law of 08 December 1992 on Privacy Protection, Law of 22 August 2002 on patients' rights and GDPR): A number will identify each subject. Only the PI and co-PI will have the ability to link the subject's number to his/her medical file. All data will be stored in a database, which will be held on CUSL' computer server. Access to data will be secured by (1) identification of PI and co-PI on their office desk and (2) by a specific password.