Status:
UNKNOWN
Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-100 years
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...
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 neutro...
Eligibility Criteria
Inclusion
- 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:
- No evidence of inflammatory arthritis on clinical examination AND
- 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 :
- No history of RA
- No FDRs with RA
- No systemic use of immunosuppressants for autoimmune disease
- RA Diagnosis:
- Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed by medical chart review) OR
- Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart review)
Exclusion
- Currently pregnant or planning to become pregnant during the sample collection period of the study
- Exacerbation of underlying obstructive lung disease within the past 1 month
- Known FEV1 \<1 liter
- Oxygen requirement \>2 liters at rest
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 14 2025
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT04474392
Start Date
August 1 2020
End Date
July 14 2025
Last Update
June 14 2022
Active Locations (1)
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1
University of Colorado Denver (Anschutz Medical Campus)
Aurora, Colorado, United States, 80045