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临床试验/NCT05366608
NCT05366608已完成不适用

14.0- 3.0- 3.0- η Protein is Associated With Disease Activity and Osteoporosis in Patients With Rheumatoid Arthritis

Mansoura University1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
188
试验地点
1
主要终点
primary

研究概览

简要总结

Aim of work: to explore the potential association between serum 14.0-3.0-3.0- η protein level with disease activity and bone mineral density (BMD) in Egyptian patients with rheumatoid arthritis (RA).

188 patients with RA and 192 matched controls were enrolled. The RA activity parameters were evaluated in RA patients. BMD was measured. Serum level of 14.0- 3.0- 3.0- η protein and IL_.6 were estimated for all participants by ELISA.

详细描述

A total of 200 RA patients were invited to be enrolled in this study. Patients were diagnosed as having RA by the 2010 European-league-against-Rheumatism- (EULAR) and American-College-of-rheumatology (ACR) classification criteria for RA. Patients were collected from the outpatient clinic of the Rheumatology and Rehabilitation Department, Mansoura University Hospital.

All participants underwent detailed medical history taking as well as clinical examination. The medical records of all patients were carefully reviewed. Data collection included age, gender, past medical history, current and past drug intake. In RA patients, the disease duration, duration of the morning stiffness, tender joint count (TJC) and swollen joint count (SJC) were reported. The activity of RA was measured by disease activity score 28 (DAS.28) based on the erythrocyte sedimentation rate (ESR) level (DAS28-ESR) [19]. The intensity of perceived pain was assessed by the visual analog scale (VAS) 100-mm scale.

Bone mineral density (BMD) was measured using dual energy X-ray absorptiometry (DEXA) at proximal femur for all participants who were categorized into normal, osteopenic, or osteoporotic according to the definition of the World Health Organization (WHO) of the recorded T score A commercially available human IL_.6 ELISA kit (GenProbe, Diaclone, France) was used to measure IL_.6 serum level following the instructions of the manufacturer.

Serum level of 14.0- 3.0- 3.0- η protein was determined by ELISA for all participants,

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were diagnosed as having RA by the 2010 European-league-against-Rheumatism- (EULAR) and American-College-of-rheumatology (ACR) classification criteria for RA Patients were collected from the outpatient clinic of the Rheumatology and Rehabilitation Department, Mansoura University Hospital

排除标准

  • postmenopausal females, patients with other rheumatic autoimmune diseases, severe infection, diabetes mellitus, hypertension, liver or kidney disease, malignancies, endocrinal diseases, pregnant or lactating females. Patients with current intake of glucocorticoids, anticonvulsants, estrogen or anti-coagulant, alcohol users, or other factors that lead to secondary osteoporosis were also excluded from the study

结局指标

主要结局

primary

时间窗: 2 years

potential association between serum 14.0-3.0-3.0- η protein level with disease activity

次要结局

  • secondry(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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