Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

NCT ID: NCT04227535

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-03

Study Completion Date

2027-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Interstitial Lung Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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


* 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

SELECTION OF CONTROLS:


\- Lack of signed informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe DIEUDE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Bichat Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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K170801J

Identifier Type: -

Identifier Source: org_study_id

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