Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Factors of ILD in Newly Diagnosed Rheumatoid Arthritis (FIND-RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002765
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Diagnostic Test: pulmonary function tests Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Factors of ILD in Newly Diagnosed Rheumatoid Arthritis
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
New RA patients
  • 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
Diagnostic Test: pulmonary function tests
  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)
Other Name: High-resolution CT scanner




Primary Outcome Measures :
  1. Presence of an interstitial lung disease [ Time Frame: from enrollment of patient to 3 months post enrollment ]
    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).


Secondary Outcome Measures :
  1. Proportion of different ILD subtypes [ Time Frame: from enrollment of patient to 3 months post enrollment ]
    usual interstitial pneumonia, non-specific interstitial pneumonia, others

  2. Proportion of patients presenting with a non-ILD lung involvement of RA [ Time Frame: from enrollment of patient to 3 months post enrollment ]
    Non-ILD lung involvement is a composite of the following variables: rheumatoid nodules, emphysema, bronchiectasis and bronchiolitis obliterans

  3. rs35705950 variant of the MUC5B promoter [ Time Frame: from enrollment of patient to 3 months post enrollment ]
    Proportion of patients carrying the variant rs35705950 of the MUC5B promoter

  4. anti-CCP antibodies [ Time Frame: from enrollment of patient to 3 months post enrollment ]
    Proportion of patients with anti-CCP antibodies

  5. relevant exposure [ Time Frame: from enrollment of patient to 3 months post enrollment ]
    Proportion of patients with a relevant toxic exposure (smoking, drug, occupational or domestic exposure)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy
  • Inability to provide informed consent
  • Inability to perform lung function tests or to comply with the protocol
  • Active pulmonary infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002765


Contacts
Layout table for location contacts
Contact: Antoine Froidure, MD PhD 003227642832 antoine.froidure@uclouvain.be

Locations
Layout table for location information
Belgium
Cliniques universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Antoine Froidure, MD PhD    0032(0)327642832    antoine.froidure@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Layout table for investigator information
Study Director: Antoine Froidure, MD PhD Cliniques universitaires Saint-Luc
Principal Investigator: Patrick Durez, MD PhD Cliniques universitaires Saint-Luc
Principal Investigator: Benoît Ghaye, MD PhD Cliniques universitaires Saint-Luc
Layout table for additonal information
Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04002765    
Other Study ID Numbers: PNEU-ILD-03
2019/21JUI/269 ( Other Identifier: CEHF )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases