NCT04474392已完成不适用
Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Sputum anti-CCP antibodies predicting incident RA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Familial risk includes having a first degree relatives (FDRs) with RA
- •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)
排除标准
- •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.
- •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
研究组 & 干预措施
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
干预措施: N/A (Observational Study) (Other)
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
干预措施: N/A (Observational Study) (Other)
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
干预措施: N/A (Observational Study) (Other)
结局指标
主要结局
Sputum anti-CCP antibodies predicting incident RA
时间窗: 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
次要结局
- The role of sputum macrophage phagocytosis in NET clearance(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)
- Effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils(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)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Registry for African Americans With Early Rheumatoid ArthritisRheumatoid ArthritisNCT00074555National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)357
已完成
不适用
Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Participants With Rheumatoid Arthritis (RA) Who Are Treated With Abatacept or Tumor Necrosis Factor Inhibitors in AustraliaRheumatoid ArthritisNCT03663829Bristol-Myers Squibb2,052
已完成
4 期
Use of Acthar in Rheumatoid Arthritis (RA) Related FlaresRheumatoid Arthritis (RA)NCT02541955Veena Ranganath, MD, MS40
Unknown
不适用
Diagnostic Utility of Anti MCV Antibodies,Anti CCPantibodies and RF in RARheumatoid ArthritisNCT03224377Assiut University80
已完成
不适用
A Study on the Prevalence of the Modified Citrullinated Vimentin Anti-body (Anti-MCV) in an Irish Rheumatoid Arthritis (RA) Population and to Assess the Impact of Anti-MCV and the Anti-cyclic-citrullinated Peptide Antibody (Anti-CCP) Status on the Management of Irish Patients With Early RARheumatoid ArthritisNCT01078597AbbVie (prior sponsor, Abbott)35