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临床试验/NCT02370771
NCT02370771已完成不适用

Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis

研究概览

简要总结

Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from which mechanisms may differ.

Methods:

This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in consultation of rheumatology and plastic surgery in Rouen University Hospital.

Two groups of patients will be studied: 20 patients with non erosive subtype of hand osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.

A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female gender
  • Less than 70 years old
  • Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of thumb base osteoarthritis:
  • Hand pain, aching or stiffness most of the days during the preceding month
  • Hard tissue enlargement of at least two of 8 selected joints *
  • Hard tissue enlargement of at least two distal interphalangeal joint
  • Swelling of fewer than three metacarpophalangeal joint
  • Deformity of at least one of 10 selected joints * Patients have to fulfil criteria 1, 2 AND 3 + 4 OR 5 * the 8 selected joints are the second and third distal interphalangeal joint and the second and third proximal interphalangeal of both hands Then confirm by experts' committee
  • Exclusively symptomatic treatment
  • For women of child-bearing age, use of an effective contraceptive method
  • French spoken and read

排除标准

  • Male gender
  • More than 70 years old
  • Hemochromatosis
  • Inflammatory arthritis
  • Cristal induced arthritis
  • Active diseases such as infection or cancer
  • Use of DMARDs
  • Pregnant or breast-feeding woman

结局指标

主要结局

Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis

时间窗: day 1

Assessments done using biological sampling

次要结局

  • Number of Erosion in patients affected by hand osteoarthritis(Day 1)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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