Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

SELECTION OF CASES :

Inclusion Criteria:

- 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

Exclusion Criteria:

- Lack of signed informed consent SELECTION OF CONTROLS:

Inclusion Criteria:

- Age ≥18 years - RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist

Exclusion Criteria:

- Lack of signed informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04227535
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Philippe DIEUDE, MD, PhD
Principal Investigator Affiliation Assistance Publique - Hôpitaux de Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Interstitial Lung Disease
Additional Details

This is not an interventional study. This is a study designed to recruit individuals affected by RA and investigate associated ILD to better understand the clinical phenotypes and genetic/molecular endotypes of RAILD, including the prognosis of the disease.

Arms & Interventions

Arms

: Rheumatoid arthritis - Interstitial lung disease patients

Assessment are as follows : 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) Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance Radiologic: chest HRCT scan Genetic: DNA, mRNA Biologic: serum

: Rheumatoid arthritis - no Interstitial lung disease patients

Assessment are as follows : 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) Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance Radiologic: chest HRCT scan Genetic: DNA, mRNA Biologic: serum

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bichat Hospital, Paris, France

Status

Recruiting

Address

Bichat Hospital

Paris, , 75018

Terms of Service

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