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Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis (ACPPPA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03832374
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Descriptive

Study Design
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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of the Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis in the West Indies
Actual Study Start Date : June 2, 2016
Actual Primary Completion Date : March 2022
Actual Study Completion Date : March 2022

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Frequency of the positivity of the anti citrullinated peptide antibodies and subtype [ Time Frame: three years ]
    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


Secondary Outcome Measures :
  1. Genetic analysis of the main mutations [ Time Frame: three years ]
    Presence of mutation TERT, RTEL1, PARN et SFTPC


Biospecimen Retention:   Samples With DNA
plasma, urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with rheumatoid arthritis with diffuse insterstitial lung disease
Criteria

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
Contacts and Locations
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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): NCT03832374


Locations
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Martinique
CHU Martinique
Fort-de-France, Martinique, 97261
Sponsors and Collaborators
University Hospital Center of Martinique
Investigators
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Principal Investigator: BLETTERY Marie, MD CHU de Martinique
More Information
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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03832374    
Other Study ID Numbers: 15/E/27
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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