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临床试验/NCT03429426
NCT03429426Enrolling By Invitation不适用

An Observational Study of Bone Erosion Determination and Progression in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 625 人开始时间: 2018年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
625
试验地点
1
主要终点
Erosion changes by HR-pQCT

研究概览

简要总结

Today, regular X-ray examination is not sufficiently sensitive for detecting progression of bone destruction in rheumatoid arthritis, but a new type of high-resolution CT scanner, the High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) can detect very early and minor joint injuries.

The purpose of this study is to use HR-pQCT techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis.

详细描述

The design of the trial is an observational study with three distinct groups. At the start of the trial period and at one-year of follow-up, the trial subject will have their hand X-rayed by conventional radiography, and their metacarpophalangeal (MCP) joint and wrist scanned by HR-pQCT-Imaging. The 28-joint Disease Activity Score(DAS28-CRP), Health Assessment Questionnaire (HAQ), Visual analogue scale(VAS)-score for pain, fatigue and quality of life are performed to investigate the correlation between radiographic changes and disease activity. Blood samples are collected to investigate serological markers of bone metabolism and inflammation and the radiographic changes. The following groups are investigated:

  • Rheumatoid Arthritis(RA): Patients with RA ≥5 years according to the ACR/EULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. Treatment will be adjusted according to the patient's need and according to national guidelines. (n=450)
  • Pre-RA patients: Patients with pre-RA, (joint pain, but no swelling and Anti-CCP 3 times above the upper limit) are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. (n=75)
  • Healthy subjects: Healthy age- and sex-matched Individuals are recruited, as a control group, by posting at libraries in Aarhus, Aarhus University, Aarhus University Hospital and postings on the websites www.forsøgsperson.dk and www.Sundhed.dk. (N=100)

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Erosion changes by HR-pQCT

时间窗: One year

Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.

Volumetric bone mineral density(vBMD) changes by HR-pQCT

时间窗: One year

Changes in volumetric bone mineral density(vBMD) in mgHA/cm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.

次要结局

  • TNF-α(one year)
  • BGLAP(one year)
  • IL-6(one year)
  • Radiographic erosion score(One year)
  • P1NP(one year)
  • IL-22(one year)
  • IL-33(one year)
  • CCL11(one year)
  • CXCL13(one year)
  • CRP(one year)
  • CTX(one year)
  • BAP(one year)
  • RANK-L(one year)
  • OPG(one year)
  • IL-1(one year)
  • IL-17(one year)
  • TRACP 5b(one year)
  • SCL(one year)
  • Dkk-1(one year)
  • Disease Activity Score(one year)
  • Health Assessment Questionnaire(one year)
  • VAS for pain(one year)
  • IL-15(one year)
  • IL-16(one year)
  • VAS for fatigue(one year)
  • VAS for quality of life(one year)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rasmus Klose-Jensen

MD, PhD Student

Aarhus University Hospital

研究点 (1)

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