Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT04474392
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04474392
Study Brief:
Protocol Section:
NCT04474392