Role of Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) as a Marker of Activity in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 28 swollen joints count
研究概览
简要总结
This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with recent onset RA before and after initiation of therapy
详细描述
- Technical design:
Study design: a longitudinal observational cohort study.
This study will be carried out on two groups:
- Group (I): fifty early onset rheumatoid arthritis (RA) patients fulfilled the 2010 American college of rheumatology (ACR) - European league against rheumatism (EULAR) classification criteria for RA [11].
- Group (II): Twenty healthy individuals of matching age and sex as control group.
Both groups will be recruited from the in-patients and out-patients' clinic of the Rheumatology, Rehabilitation& Physical Medicine Department, Benha University Hospital.
All patients will be evaluated at baseline at 6 months follow up using:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed
排除标准
- •infection malignancy receiving treatment
结局指标
主要结局
28 swollen joints count
时间窗: 4 months
swollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
disease activity score of 28 joint count (DAS28)
时间窗: 4 months
DAS28 is calculated from tender and swollen joint counts , ESR and patient's global assessment of disease activity according to the following formula DAS28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* global patient assesment
grey scale12 joint score
时间窗: 4 months
grey scale musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following greyscale synovitis semiquantitative grades were assumed: Grade 0: absent. Grade 1: mild with anechoic / hypoechoic line below the capsule of the joint. Grade 2: moderate with elevation of the joint capsule that becomes parallel to the area of the joint. Grade 3: severe with marked distension of the capsule.
power Doppler 12 joint score
时间窗: 4 months
power Doppler musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following power Doppler synovitis grades were assumed: Grade 0: no colour signal inside joint area. Grade 1: up to 3 colour signals inside joint area. Grade 2: colour signals less than half of joint area and more than grade 1. Grade 3: colour signals more than half of joint area.
anticyclic citrullinated antibody (Anti CCP)
时间窗: 4 months
Anti CCP measured in Unit/ml using ELISA
28 tender joints count
时间窗: 4 months
tender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
rheumatoid factor
时间窗: 4 months
rheumatoid factor measured in U/ml using latex agglutination test
patient's global assessment of disease activity
时间窗: 4 months
patient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst.
erythrocyte sedimentation rate (ESR)
时间窗: 4 months
ESR measured in mm/1st hour by westergren method
C reactive protein (CRP)
时间窗: 4 months
CRP measured in mg/L using nephlometry
次要结局
未报告次要终点
研究者
Waleed Ahmed Salaheldeen Hassan
Assistant professor
Benha University