"Matrix Metalloproteinases 7 and 9 in Rheumatoid Arthritis Patients With Interstitial Lung Disease and Its Relation to Disease Activity"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- 1. Creation of a statistical relation between Matrix Metalloprotienases 7 and 9 concentrations and the severity of the RA. 2. Creation of a statistical relation between MMPs concentrations and development of ILD.
研究概览
简要总结
This case control study will be done at Rheumatology Department, Assiut University Hospital. It will include RA patients fulfilling the American College of Rheumatology and European League against Rheumatism (ACR / EULAR) 2010 classification criteria.
Aim of the study
- To assess the matrix metalloproteinase 7 and 9 (MMP7,9) as a screening tool for interstitial lung disease in rheumatoid arthritis patients and to assess for correlation with RA-disease activity.
- To investigate whether certain MMPs could be potential biomarkers reflecting the lung fibrotic process in RA patients.
- To assess the capillaroscopy changes in RA and RA-ILD.
- To detect correlation between MMPs and capillaroscopic changes in RA patients. This case control study will be done at Rheumatology Department, Assiut University Hospital. It will include RA patients fulfilling the American College of Rheumatology and European League against Rheumatism (ACR / EULAR) 2010 classification criteria.
The patients will be divided into 3 groups:
Group (1): RA patients with ILD. Group (2): RA patients without ILD Group (3): Healthy controls
All patients will be subjected to:
A- Complete medical history:
Detailed medical history will be taken including demographic data (age, sex, disease duration, morning stiffness, joint involvement, smoking, habits of medical importance), articular and extra articular manifestations. Detailed respiratory manifestations as (dyspnea, cough, chest wheeze, others)
B- Clinical examination:
- General and local rheumatological examination.
- Local chest examination (inspection, palpation, percussion, auscultation).
- Assessment of RA disease activity using DAS 28 ESR. Score interpretation <2.6 suggests disease remission. 2.6-3.2 suggests low disease activity 3.2-5.1 suggests moderate disease activity >5.1 suggest high disease activity
C- Laboratory investigations:
Peripheral venous blood samples for CBC, C-reactive protein, erythrocyte sedimentation rate, antibody status.
D- Radiology and PFT:
PFTs and HRCT chest patterns will be done for patients.
E- MMP measurement:
Serum samples will be collected at the time of registry enrollment, MMP 7 and 9 concentrations will be measured using enzyme-linked immunosorbent assas.
This ELISA kit uses the Sandwich-ELISA principle.
详细描述
Introduction Rheumatoid arthritis (RA) is a systemic inflammatory disorder most commonly affects the joints, causing progressive, symmetric, erosive destruction of cartilage and bone, usually associated with autoantibody production. Although joint disease is the main presentation, there are several extra-articular manifestations including subcutaneous nodule formation, vasculitis, inflammatory eye disease and lung disease. Of these manifestations, lung disease is a major contributor to morbidity and mortality.
Clinically significant interstitial lung disease (ILD) occurs in approximately 5% to 15% of people with rheumatoid arthritis (RA).
The prognosis after RA-ILD diagnosis is poor, with the observed median survival being between 3 and 8 years. For the poor prognosis and emerging immunomodulatory and antifibrotic treatment options, there is substantial interest in identifying RA-ILD at an early stage.
Clinical and epidemiologic studies have identified older age, male sex, cigarette smoking, higher RA disease activity, RA autoantibodies, and genetic factors as risk factors for RA-ILD.
In addition to autoantibodies and select genetic variants, other categories of candidate biomarkers evaluated in RA-ILD to date have included extracellular matrix proteins, cytokines and chemokines, lung epithelial-related proteins, tumor markers, and growth factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- Age >
- •2- RA diagnosis according (ACR / EULAR) 2010.
排除标准
- •Age <18 years.
- •Other connective tissue diseases (systemic sclerosis, systemic Lupus and Mixed connective tissue disease)
- •Another chest presentation
- •Patient refuse
- •Patients with recent nail trauma
- •Patients with heavy manual activities
- •Poor nailfold hygiene
- •Congestive heart failure
- •Individuals unable to cooperate during the nailfold capillaroscopic examination.
结局指标
主要结局
1. Creation of a statistical relation between Matrix Metalloprotienases 7 and 9 concentrations and the severity of the RA. 2. Creation of a statistical relation between MMPs concentrations and development of ILD.
时间窗: at time of enrollement
1\. Creation of a statistical relation between MMPs concentrations and the severity of the RA. 2. Creation of a statistical relation between MMPs concentrations and development of ILD. Secondary Outcome Measure
次要结局
- Nailfold capillaroscopic patterns in rheumatoidarthritis patients(1 year)
研究者
Nisreen mohamed abdelbary hussein
"Matrix Metalloproteinases 7 and 9 in Rheumatoid Arthritis patients with Interstitial Lung disease and its relation to disease activity
Assiut University