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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03832374
Other study ID # 15/E/27
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2016
Est. completion date March 2022

Study information

Verified date March 2022
Source University Hospital Center of Martinique
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial pneumopathy and bronchial disorders. According to the literature review, the prevalence of PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is responsible for a significant morbidity and mortality, is currently under-diagnosed and its treatment is poorly codified. The lung seems to have a central role in the genesis of rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide antibodies are preferentially present in the lungs. The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary airways. Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects with rheumatoid arthritis.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date March 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with rheumatoid arthritis ACR/EULAR 2010 - Patient with a higher age or equal to 18 - Patient receiving social security - Patient giving his free and informed written consent Exclusion Criteria: - Patient with overlap syndrome with another autoimmune disease - Patients with known severe cardiopulmonary pathology - Woman who is pregnant and breast feeding - Patient with language difficulties or understanding

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Descriptive


Locations

Country Name City State
Martinique CHU Martinique Fort-de-France

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of the positivity of the anti citrullinated peptide antibodies and subtype Presence of one or more subtypes of anti citrullinated peptide antibodies in the serum of patients with interstitial pneumopathy associated with rheumatoid arthritis who would be absent three years
Secondary Genetic analysis of the main mutations Presence of mutation TERT, RTEL1, PARN et SFTPC three years
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