NCT03832374

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 2, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

5.7 years

First QC Date

October 29, 2018

Last Update Submit

March 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Genetic analysis of the main mutations

    three years

Interventions

Eligibility Criteria

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

Patients with rheumatoid arthritis with diffuse insterstitial lung disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Martinique

Fort-de-France, 97261, Martinique

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, urine

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • BLETTERY Marie, MD

    CHU de Martinique

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 29, 2018

First Posted

February 6, 2019

Study Start

June 2, 2016

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations