Investigating the link between lung inflammation and rheumatoid arthritis

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

This study is trying to see if lung inflammation and certain markers in sputum can help predict the development of rheumatoid arthritis in people.

Quick facts

• Study type: Observational
• Enrollment: 340 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT04474392 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the causes of rheumatoid arthritis (RA) by examining the relationship between autoantibodies in sputum and lung inflammation. It will identify whether sputum anti-CCP can predict the onset of RA, assess the impact of inflammatory cytokines on neutrophil activity, and evaluate the role of macrophages in clearing neutrophil extracellular traps (NETs). The findings are expected to enhance understanding of RA development and inform future prevention strategies targeting lung inflammation to mitigate joint damage.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-100 who are at risk for RA, have a confirmed RA diagnosis, or are healthy controls without a history of RA.

Not a fit: Patients currently pregnant or those with exacerbations of underlying obstructive lung disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved screening and prevention strategies for rheumatoid arthritis, potentially reducing the need for systemic therapies.

How similar studies have performed: While this study explores a novel approach, previous studies have indicated potential links between autoantibodies and RA, suggesting a promising area of investigation.

Eligibility 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

Where this trial is running

Aurora, Colorado

• University of Colorado Denver (Anschutz Medical Campus) — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Kristen Demoruelle, MD, PhD — University of Colorado, Denver
• Study coordinator: Kasey Bales

Conditions Rheumatoid Arthritis