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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04474392
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kristen Demoruelle, MD, PhD
Principal Investigator Affiliation	University of Colorado, Denver
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis

Additional Details

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
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.

Arms & Interventions

Arms

: At-Risk (N=180)

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 There will be 1 study visit per year for 3 years; for a subset of 30 of these participants, there will be an additional 3 quarterly visits in one year. Study Procedures (Baseline & Follow-up): Questionnaires Physical and joint exam Measurement of participants' height, weight Blood and sputum collection

: Healthy Controls (N=120)

No history of RA No FDRs with RA No systemic use of immunosuppressants for autoimmune disease Participants will return for 1 follow-up visit, approximately 1 year after their baseline visit. Study Procedures (Baseline & Follow-up): Questionnaires Physical and joint exam Measurement of participants' height, weight Blood and sputum collection

: RA Diagnosis (N=40)

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) Participants will return for 1 follow-up visit, approximately 1 year after their baseline visit. Study Procedures (Baseline & Follow-up): Questionnaires Physical and joint exam Measurement of participants' height, weight Blood and sputum collection

Interventions

Other: - N/A (Observational Study)

Observational study, no intervention will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Denver (Anschutz Medical Campus)

Aurora, Colorado, 80045

Site Contact

Kasey Bales

[email protected]

303-724-0071

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