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NCT04474392 | RECRUITING | Rheumatoid Arthritis

Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins
Sponsor:

University of Colorado, Denver

Brief Summary:

The study is designed to learn more about the causes of rheumatoid arthritis (RA). People who get RA have elevated protein markers called autoantibodies in their blood years before initial symptoms of arthritis. The goal of this study is to learn more about how autoantibodies in RA might be related to inflammation in the lungs.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

N/A (Observational Study)

Detailed Description:

The Specific Aims of This Study Are As Follows: 1. Identify whether sputum anti-CCP predicts incident RA 2. Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils 3. Determine the role of sputum macrophage phagocytosis in NET clearance \<br\> The knowledge gained from this study will improve the overall understanding of the development of RA. It is anticipated that these findings will improve the field's understanding of how best to screen for RA risk and target RA prevention. This study could support future lung-targeted prevention strategies for RA that could avoid the administration of systemic toxic therapies. Such potential prevention interventions could be implemented in subjects at risk for RA in order to prevent the irreversible joint damage that can occur in the later stages of clinically-apparent RA.

Study Type : OBSERVATIONAL
Estimated Enrollment : 340 participants
Official Title : Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins
Actual Study Start Date : 2020-08-01
Estimated Primary Completion Date : 2025-07-14
Estimated Study Completion Date : 2025-07-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Adults between 18 and 100 years;
  • * At-Risk for RA, RA diagnosed, and Healthy Control subjects will be included in the study until recruitment goals are met for each group.
  • At-Risk
    • 1. No evidence of inflammatory arthritis on clinical examination AND
    • 2. At elevated risk for RA based on familial or serologic risk
    • * Familial risk includes having a first degree relatives (FDRs) with RA
    • * Serologic risk includes asymptomatic serum ACPA positivity
    • Healthy Controls
      • 1. No history of RA
      • 2. No FDRs with RA
      • 3. No systemic use of immunosuppressants for autoimmune disease
      • RA Diagnosis
        • 1. Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed by medical chart review) OR
        • 2. Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart review)
        Exclusion Criteria
        • 1. Currently pregnant or planning to become pregnant during the sample collection period of the study
        • 2. Exacerbation of underlying obstructive lung disease within the past 1 month
        • 3. Known FEV1 \<1 liter
        • 4. Oxygen requirement \>2 liters at rest
        • 5. Participants with health acuity or behavioral health concerns leaving them unable to participate in the current research
        • Note: If a subject temporarily does not meet inclusion criteria but is interested in participating, he/she may participate once inclusion criteria have been met.
        • If interested, please take a few minutes to complete the screening questionnaire for this study opportunity. You may open the survey in your web browser by clicking the link below
          • https://is.gd/SPAROscreen
          • If the link above does not work, try copying the link below into your web browser
            • https://redcap.ucdenver.edu/surveys/?s=3WM8WH3WKK
Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins

Location Details

NCT04474392

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado Denver (Anschutz Medical Campus)

Aurora, Colorado, United States, 80045