Rheumatoid ArthritisSPARONCT04474392
Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins
An observational study of Rheumatoid Arthritis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- N/A (Observational Study)
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 14 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver (Anschutz Medical Campus)
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
The Specific Aims of This Study Are As Follows:
- Identify whether sputum anti-CCP predicts incident RA
- Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
- Determine the role of sputum macrophage phagocytosis in NET clearance <br> 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- N/A (Observational Study)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A (Observational Study)Other
Observational study, no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| At-Risk (N=180) | 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 Receives: Other: N/A (Observational Study) | |
| Healthy Controls (N=120) | 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 Receives: Other: N/A (Observational Study) | |
| RA Diagnosis (N=40) | 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 Receives: Other: N/A (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum anti-CCP antibodies predicting incident RA
*Sputum anti-CCP antibodies every year for 3 years (subjects At-Risk for RA); to identify whether sputum anti-CCP predicts incident RA
Measured: 1-3 years per participant (depending on group); study visits x1 per year, with option for 3 additional visits over 1 year for a subgroup of participants.
Secondary outcomes (2)
Effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
*Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
Measured: 1-3 yrs / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later
The role of sputum macrophage phagocytosis in NET clearance
*Determine the role of sputum macrophage phagocytosis in NET clearance among At-Risk, healthy, \& RA subjects
Measured: 1-3 years / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Aug 2020
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Kristen Demoruelle, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474392
- Sponsor's protocol ID
- 20-0206
- Other IDs
- 1R01AR076450-01
- Acronym
- SPARO
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Allaire S, Wolfe F, Niu J, Lavalley MP. Contemporary prevalence and incidence of work disability associated with rheumatoid arthritis in the US. Arthritis Rheum. 2008 Apr 15;59(4):474-80. doi: 10.1002/art.23538.
PubMed 18383413van der Woude D, Young A, Jayakumar K, Mertens BJ, Toes RE, van der Heijde D, Huizinga TW, van der Helm-van Mil AH. Prevalence of and predictive factors for sustained disease-modifying antirheumatic drug-free remission in rheumatoid arthritis: results from two large early arthritis cohorts. Arthritis Rheum. 2009 Aug;60(8):2262-71. doi: 10.1002/art.24661.
PubMed 19644846Ogdie A, Haynes K, Troxel AB, Love TJ, Hennessy S, Choi H, Gelfand JM. Risk of mortality in patients with psoriatic arthritis, rheumatoid arthritis and psoriasis: a longitudinal cohort study. Ann Rheum Dis. 2014 Jan;73(1):149-53. doi: 10.1136/annrheumdis-2012-202424. Epub 2012 Dec 21.
PubMed 23264338Birnbaum H, Pike C, Kaufman R, Marynchenko M, Kidolezi Y, Cifaldi M. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin. 2010 Jan;26(1):77-90. doi: 10.1185/03007990903422307.
PubMed 19908947Deane KD, Striebich CC, Holers VM. Editorial: Prevention of Rheumatoid Arthritis: Now Is the Time, but How to Proceed? Arthritis Rheumatol. 2017 May;69(5):873-877. doi: 10.1002/art.40061. Epub 2017 Apr 11. No abstract available.
PubMed 28217918Hunt L, Hensor EM, Nam J, Burska AN, Parmar R, Emery P, Ponchel F. T cell subsets: an immunological biomarker to predict progression to clinical arthritis in ACPA-positive individuals. Ann Rheum Dis. 2016 Oct;75(10):1884-9. doi: 10.1136/annrheumdis-2015-207991. Epub 2015 Dec 1.
PubMed 27613874Harre U, Georgess D, Bang H, Bozec A, Axmann R, Ossipova E, Jakobsson PJ, Baum W, Nimmerjahn F, Szarka E, Sarmay G, Krumbholz G, Neumann E, Toes R, Scherer HU, Catrina AI, Klareskog L, Jurdic P, Schett G. Induction of osteoclastogenesis and bone loss by human autoantibodies against citrullinated vimentin. J Clin Invest. 2012 May;122(5):1791-802. doi: 10.1172/JCI60975. Epub 2012 Apr 16.
PubMed 22505457Kuhn KA, Kulik L, Tomooka B, Braschler KJ, Arend WP, Robinson WH, Holers VM. Antibodies against citrullinated proteins enhance tissue injury in experimental autoimmune arthritis. J Clin Invest. 2006 Apr;116(4):961-73. doi: 10.1172/JCI25422.
PubMed 16585962Clavel C, Nogueira L, Laurent L, Iobagiu C, Vincent C, Sebbag M, Serre G. Induction of macrophage secretion of tumor necrosis factor alpha through Fcgamma receptor IIa engagement by rheumatoid arthritis-specific autoantibodies to citrullinated proteins complexed with fibrinogen. Arthritis Rheum. 2008 Mar;58(3):678-88. doi: 10.1002/art.23284.
PubMed 18311806Titcombe PJ, Wigerblad G, Sippl N, Zhang N, Shmagel AK, Sahlstrom P, Zhang Y, Barsness LO, Ghodke-Puranik Y, Baharpoor A, Hansson M, Israelsson L, Skriner K, Niewold TB, Klareskog L, Svensson CI, Amara K, Malmstrom V, Mueller DL. Pathogenic Citrulline-Multispecific B Cell Receptor Clades in Rheumatoid Arthritis. Arthritis Rheumatol. 2018 Dec;70(12):1933-1945. doi: 10.1002/art.40590. Epub 2018 Oct 18.
PubMed 29927106Engdahl C, Bang H, Dietel K, Lang SC, Harre U, Schett G. Periarticular Bone Loss in Arthritis Is Induced by Autoantibodies Against Citrullinated Vimentin. J Bone Miner Res. 2017 Aug;32(8):1681-1691. doi: 10.1002/jbmr.3158. Epub 2017 May 26.
PubMed 28425620Krishnamurthy A, Joshua V, Haj Hensvold A, Jin T, Sun M, Vivar N, Ytterberg AJ, Engstrom M, Fernandes-Cerqueira C, Amara K, Magnusson M, Wigerblad G, Kato J, Jimenez-Andrade JM, Tyson K, Rapecki S, Lundberg K, Catrina SB, Jakobsson PJ, Svensson C, Malmstrom V, Klareskog L, Wahamaa H, Catrina AI. Identification of a novel chemokine-dependent molecular mechanism underlying rheumatoid arthritis-associated autoantibody-mediated bone loss. Ann Rheum Dis. 2016 Apr;75(4):721-9. doi: 10.1136/annrheumdis-2015-208093. Epub 2015 Nov 26.
PubMed 26612338Wigerblad G, Bas DB, Fernades-Cerqueira C, Krishnamurthy A, Nandakumar KS, Rogoz K, Kato J, Sandor K, Su J, Jimenez-Andrade JM, Finn A, Bersellini Farinotti A, Amara K, Lundberg K, Holmdahl R, Jakobsson PJ, Malmstrom V, Catrina AI, Klareskog L, Svensson CI. Autoantibodies to citrullinated proteins induce joint pain independent of inflammation via a chemokine-dependent mechanism. Ann Rheum Dis. 2016 Apr;75(4):730-8. doi: 10.1136/annrheumdis-2015-208094. Epub 2015 Nov 27.
PubMed 26613766Demoruelle MK, Parish MC, Derber LA, Kolfenbach JR, Hughes-Austin JM, Weisman MH, Gilliland W, Edison JD, Buckner JH, Mikuls TR, O'Dell JR, Keating RM, Gregersen PK, Norris JM, Holers VM, Deane KD. Performance of anti-cyclic citrullinated Peptide assays differs in subjects at increased risk of rheumatoid arthritis and subjects with established disease. Arthritis Rheum. 2013 Sep;65(9):2243-52. doi: 10.1002/art.38017.
PubMed 23686569Rantapaa-Dahlqvist S, de Jong BA, Berglin E, Hallmans G, Wadell G, Stenlund H, Sundin U, van Venrooij WJ. Antibodies against cyclic citrullinated peptide and IgA rheumatoid factor predict the development of rheumatoid arthritis. Arthritis Rheum. 2003 Oct;48(10):2741-9. doi: 10.1002/art.11223.
PubMed 14558078
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins
- ClinicalTrials.gov ID
- NCT04474392
- Acronym / sponsor ID
- SPARO / 20-0206
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Specific Aims of This Study Are As Follows:
- Identify whether sputum anti-CCP predicts incident RA
- Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
- Determine the role of sputum macrophage phagocytosis in NET clearance <br> 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| At-Risk (N=180) | – | Other: N/A (Observational Study)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 |
| Healthy Controls (N=120) | – | Other: N/A (Observational Study)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 |
| RA Diagnosis (N=40) | – | Other: N/A (Observational Study)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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (14 listed)
- 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.
- No evidence of inflammatory arthritis on clinical examination AND
- At elevated risk for RA based on familial or serologic risk
- No history of RA
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A (Observational Study)Observational study, no intervention will be administered. | Other | At-Risk (N=180), Healthy Controls (N=120), RA Diagnosis (N=40) |
Primary outcome
Sputum anti-CCP antibodies predicting incident RA
Time frame: 1-3 years per participant (depending on group); study visits x1 per year, with option for 3 additional visits over 1 year for a subgroup of participants.
*Sputum anti-CCP antibodies every year for 3 years (subjects At-Risk for RA); to identify whether sputum anti-CCP predicts incident RA
2 secondary outcomes
Effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
Time frame: 1-3 yrs / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later
The role of sputum macrophage phagocytosis in NET clearance
Time frame: 1-3 years / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 18383413Allaire S, Wolfe F, Niu J, Lavalley MP. Contemporary prevalence and incidence of work disability associated with rheumatoid arthritis in the US. Arthritis Rheum. 2008 Apr 15;59(4):474-80. doi: 10.1002/art.23538.
- Background: PubMed 19644846van der Woude D, Young A, Jayakumar K, Mertens BJ, Toes RE, van der Heijde D, Huizinga TW, van der Helm-van Mil AH. Prevalence of and predictive factors for sustained disease-modifying antirheumatic drug-free remission in rheumatoid arthritis: results from two large early arthritis cohorts. Arthritis Rheum. 2009 Aug;60(8):2262-71. doi: 10.1002/art.24661.
- Background: PubMed 23264338Ogdie A, Haynes K, Troxel AB, Love TJ, Hennessy S, Choi H, Gelfand JM. Risk of mortality in patients with psoriatic arthritis, rheumatoid arthritis and psoriasis: a longitudinal cohort study. Ann Rheum Dis. 2014 Jan;73(1):149-53. doi: 10.1136/annrheumdis-2012-202424. Epub 2012 Dec 21.
- Background: PubMed 19908947Birnbaum H, Pike C, Kaufman R, Marynchenko M, Kidolezi Y, Cifaldi M. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin. 2010 Jan;26(1):77-90. doi: 10.1185/03007990903422307.
- Background: PubMed 28217918Deane KD, Striebich CC, Holers VM. Editorial: Prevention of Rheumatoid Arthritis: Now Is the Time, but How to Proceed? Arthritis Rheumatol. 2017 May;69(5):873-877. doi: 10.1002/art.40061. Epub 2017 Apr 11. No abstract available.
- Background: PubMed 27613874Hunt L, Hensor EM, Nam J, Burska AN, Parmar R, Emery P, Ponchel F. T cell subsets: an immunological biomarker to predict progression to clinical arthritis in ACPA-positive individuals. Ann Rheum Dis. 2016 Oct;75(10):1884-9. doi: 10.1136/annrheumdis-2015-207991. Epub 2015 Dec 1.
- Background: PubMed 22505457Harre U, Georgess D, Bang H, Bozec A, Axmann R, Ossipova E, Jakobsson PJ, Baum W, Nimmerjahn F, Szarka E, Sarmay G, Krumbholz G, Neumann E, Toes R, Scherer HU, Catrina AI, Klareskog L, Jurdic P, Schett G. Induction of osteoclastogenesis and bone loss by human autoantibodies against citrullinated vimentin. J Clin Invest. 2012 May;122(5):1791-802. doi: 10.1172/JCI60975. Epub 2012 Apr 16.
- Background: PubMed 16585962Kuhn KA, Kulik L, Tomooka B, Braschler KJ, Arend WP, Robinson WH, Holers VM. Antibodies against citrullinated proteins enhance tissue injury in experimental autoimmune arthritis. J Clin Invest. 2006 Apr;116(4):961-73. doi: 10.1172/JCI25422.
- Background: PubMed 18311806Clavel C, Nogueira L, Laurent L, Iobagiu C, Vincent C, Sebbag M, Serre G. Induction of macrophage secretion of tumor necrosis factor alpha through Fcgamma receptor IIa engagement by rheumatoid arthritis-specific autoantibodies to citrullinated proteins complexed with fibrinogen. Arthritis Rheum. 2008 Mar;58(3):678-88. doi: 10.1002/art.23284.
- Background: PubMed 29927106Titcombe PJ, Wigerblad G, Sippl N, Zhang N, Shmagel AK, Sahlstrom P, Zhang Y, Barsness LO, Ghodke-Puranik Y, Baharpoor A, Hansson M, Israelsson L, Skriner K, Niewold TB, Klareskog L, Svensson CI, Amara K, Malmstrom V, Mueller DL. Pathogenic Citrulline-Multispecific B Cell Receptor Clades in Rheumatoid Arthritis. Arthritis Rheumatol. 2018 Dec;70(12):1933-1945. doi: 10.1002/art.40590. Epub 2018 Oct 18.
- Background: PubMed 28425620Engdahl C, Bang H, Dietel K, Lang SC, Harre U, Schett G. Periarticular Bone Loss in Arthritis Is Induced by Autoantibodies Against Citrullinated Vimentin. J Bone Miner Res. 2017 Aug;32(8):1681-1691. doi: 10.1002/jbmr.3158. Epub 2017 May 26.
- Background: PubMed 26612338Krishnamurthy A, Joshua V, Haj Hensvold A, Jin T, Sun M, Vivar N, Ytterberg AJ, Engstrom M, Fernandes-Cerqueira C, Amara K, Magnusson M, Wigerblad G, Kato J, Jimenez-Andrade JM, Tyson K, Rapecki S, Lundberg K, Catrina SB, Jakobsson PJ, Svensson C, Malmstrom V, Klareskog L, Wahamaa H, Catrina AI. Identification of a novel chemokine-dependent molecular mechanism underlying rheumatoid arthritis-associated autoantibody-mediated bone loss. Ann Rheum Dis. 2016 Apr;75(4):721-9. doi: 10.1136/annrheumdis-2015-208093. Epub 2015 Nov 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Demoruelle, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum anti-CCP antibodies predicting incident RA (time frame: 1-3 years per participant (depending on group); study visits x1 per year, with option for 3 additional visits over 1 year for a subgroup of participants.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474392, which also lists 61 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.