NCT04227535

Brief Summary

The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2020Oct 2027

First Submitted

Initial submission to the registry

July 15, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7.7 years

First QC Date

July 15, 2019

Last Update Submit

April 27, 2023

Conditions

Rheumatoid ArthritisInterstitial Lung Disease

Keywords

Rheumatoid ArthritisInterstitial lung disease

Outcome Measures

Primary Outcomes (1)

  • Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).

    whole exome sequencing data

    Baseline

Secondary Outcomes (3)

  • Identification of genetic factors implicated in RA-ILD using genome wide association study.

    Baseline

  • Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.

    Every year during 5 years

  • Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.

    Every year during 5 years

Study Arms (2)

Rheumatoid arthritis - Interstitial lung disease patients

Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum

Rheumatoid arthritis - no Interstitial lung disease patients

Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population of interest are individuals affected by RA with ILD (RA-ILD). Individuals affected with RA and without ILD (RA-noILD) will be included as a control population. The ILD status being systematically assessed by HRCT chest scan.

You may qualify if:

  • Age ≥18 years
  • RA diagnosis according to ACR (classification of rheumatoid arthritis) 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
  • ILD diagnosis based on typical High-Resolution Computed-Tomography (HCRT) patterns and pulmonary function tests (PFT), validated by a senior pulmonologist

You may not qualify if:

  • \- Lack of signed informed consent
  • SELECTION OF CONTROLS:
  • Age ≥18 years
  • RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
  • \- Lack of signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat Hospital

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood DNA, blood mRNA, serum

MeSH Terms

Conditions

Arthritis, RheumatoidLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • Philippe DIEUDE, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

January 13, 2020

Study Start

February 3, 2020

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

FR(1)