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临床试验/NCT03835624
NCT03835624已完成不适用

Interleukin 33 in Juvenile Idiopathic Arthritis Patients :Relation to Disease State and Muscloskeletal Ultrasound Findings

Benha University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年2月12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
120
试验地点
1
主要终点
disease activity for systemic arthritis with active systemic features (and without active arthritis)

研究概览

简要总结

The aim of this study is to measure serum and synovial fluid levels of IL 33 and its relative mRNA expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (JIA) patients and to correlate it with the clinical and laboratory characteristics, disease activity and musculoskeletal ultrasound findings.

详细描述

SUBJECTS AND METHODS

Subjects:This study will be a case-control study including sixty children with juvenile idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and Benha children hospital and thirty apparently healthy children as controls. They will be classified into:

  • Group (I) study group:60 cases of children with juvenile idiopathic arthritis.
  • Group (II) Control group:60 of apparently healthy children matched for age and sex

A)Full history taking

B) Full clinical examination

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children less than 16 years old diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis

排除标准

  • 1-Exclusion other causes of arthritis in children as:
  • Other autoimmune diseases Vasculitis- SLE- Rheumatic fever- Dermatomyositis- Polymyositis- Enteropathic arthritis- Behcet disease- Sjogren-Scleroderma- Mixed connective diseases
  • Infectious disease or septic arthritis.
  • Metabolic diseases.
  • Endocrine diseases.
  • Neuropathic diseases.
  • Heritable bone disease.
  • Neoplastic diseases including leukemia.
  • Sarcoidosis.
  • Familial Mediterranean fever. 2-Exclusion of children with diseases that affect serum level of IL 33 as:
  • Inflammatory diseases of airway e.g asthma
  • Inflammatory bowel disease
  • Systemic lupus erythmatosus
  • Inflammatory skin disease e.g :atopic dermatitis

结局指标

主要结局

disease activity for systemic arthritis with active systemic features (and without active arthritis)

时间窗: through study completion, an average of 4 months

DISEASE ACTIVITY LEVELS (2 levels) Active fever AND physician global assessment of overall disease activity 7 of 10 Active fever AND systemic features of high disease activity (e.g., significant serositis) that result in physician global assessment of overall disease activity 7 of 10

physician's global assessment of disease activity scale

时间窗: through study completion, an average of 4 months.

physician's global assessment of disease activity on a 0- 10 cm visual analogue scale (VAS). Higher value indicates worse outcome

The 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)

时间窗: through study completion, an average of 4 months

The JADAS-27 (range 0-57) was computed by summing the scores of four core-set criteria \[3\]: physician's global assessment of disease activity (PGA) on a 10 cm visual analogue scale (VAS); parent/patient global assessment of well-being on a 10 cm VAS \[7\]; active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints; and ESR (mm/h) normalized to a 0-10 scale, using the formula ESR - 20/10, whereby, before the calculation, ESR values \<20 mm/h were converted to 0 and ESR values \>120 mm/h were converted to 120. A higher JADAS-27 indicates higher disease activity and a lower JADAS-27 indicates lower disease activity

grey scale 10 joint score

时间窗: through study completion, an average of 4 months

grey scale musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)

parent/patient global assessment of well-being scale

时间窗: through study completion, an average of 4 months.isit to measure IL33

parent/patient global assessment of well-being on a 0-10 cm visual analogue scale .Higher value indicates worse outcome

C reactive protein (CRP)

时间窗: through study completion, an average of 4 months

CRP measured in mg/L using nephlometry

Serum ferritin level

时间窗: through study completion, an average of 4 months

Serum ferritin level measured in ng/mL using elisa

Erythrocyte sedimentation rate (ESR)

时间窗: through study completion, an average of 4 months

ESR measured in mm/1st hour by westergren method

rheumatoid factor

时间窗: through study completion, an average of 4 months

rheumatoid factor measured in U/ml using latex agglutination test

disease activity for systemic arthritis with active arthritis (and without active systemic features)

时间窗: through study completion, an average of 4 months

Low disease activity (must satisfy all) 4 or fewer active joints, ESR or CRP level normal PGA of disease activity less than4 of, 10 PAGA of well-being 2 of 10 Moderate disease activity (does not satisfy criteria for low or high disease activity) High disease activity (must satisfy at least 3) 8 or more active joints,ESR or CRP level greater than twice upper limit of normal, PGA of disease activity 7 of 10, PAGA of well-being 5 of 10

27 active joints count

时间窗: through study completion, an average of 4 months

active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints

power Doppler 10 joint score

时间窗: through study completion, an average of 4 months

power Doppler musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)

The Juvenile Arthritis Multidimensional Assessment Report

时间窗: through study completion, an average of 4 months

The JAMAR is a questionnaire includes the following 15 sections: Assessment of physical function (PF) using 15-items with score 0-45. Higher scores indicating higher degree of disability 2. 21-numbered circle Visual Analogue Scale (VAS) for pain 3. Assessment of the presence of joint pain or swelling.4.Assessment of morning stiffness 5. extra-articular symptoms (fever and rash) 6.disease activity on a 21-circle VAS. 7.disease status. 8. course. 9.medications . 10. side effects. 11.difficulties with medication 12. school/university/work problems. 13. HRQoL 14.patient's overall well-being on a 21-numbered circle VAS. 15. satisfaction with outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Waleed Ahmed Salaheldeen Hassan

Assistant professor

Benha University

研究点 (1)

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