CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 340 enrolled / 340 target
Drug / intervention
N/A (Observational Study)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04474392
NCT04474392N/ACompletedHigh Momentum (4.8/mo)Completion was 5mo ago

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

University of Colorado, Denver·observational·Posted Jul 16, 2020·Updated Jun 16, 2026

In Brief

An observational study evaluating N/A (Observational Study) for Rheumatoid Arthritis. Completed, enrolled 340 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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 arthritis. The goal of this study is to learn more about how autoantibodies in RA might be related to inflammation in the lungs.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 16, 2020
Enrollment StartAug 1, 2020
Primary CompletionJan 14, 2026
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 6.0 years ago

Arms & Interventions

At-Risk (N=180)other

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 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

Other: N/A (Observational Study)
Healthy Controls (N=120)other

1. No history of RA 2. No FDRs with RA 3. 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

Other: N/A (Observational Study)
RA Diagnosis (N=40)other

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) 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

Other: N/A (Observational Study)

Interventions

N/A (Observational Study)other

Observational study, no intervention will be administered.