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Lung clues could unlock early rheumatoid arthritis detection

NCT ID NCT04474392

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 340 people to understand how certain proteins in the lungs, called autoantibodies, might be linked to the start of rheumatoid arthritis (RA). Researchers collected sputum (mucus from the lungs) from people at risk for RA, those already diagnosed, and healthy volunteers. The goal was to see if these lung proteins could predict who will develop RA, offering a window into the disease's early origins.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could help identify early warning signs of rheumatoid arthritis, potentially leading to earlier diagnosis or prevention strategies.
What could go wrong
This is an observational study, not a treatment trial. It aims to understand disease origins, not test a therapy, so direct patient benefits are not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

340 people

The number who actually took part.

Started

Aug 2020

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

We will recruit subjects from 1) the Denver site of the SERA project (COMIRB #01-0675); 2) local rheumatology clinics, including the University of Colorado Hospital (UCH), Denver Health, National Jewish Health (NJH), and the Denver Arthritis Clinic; 3) local health clinics at UCH; and 4) local advertisements.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • University of Colorado Denver (Anschutz Medical Campus)

    Aurora, Colorado, 80045, United States

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