此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)

2021年1月12日 更新者：Rasmus Klose-Jensen、Aarhus University Hospital

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

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.

研究概览

地位

邀请报名

条件

详细说明

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)

研究类型

观察性的

注册 (预期的)

625

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Aarhus、丹麦、8000
        • Department of Rheumatology, Aarhus University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Rheumatoid arthritis patients and pre-rheumatoid patients are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital.

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.

描述

Rheumatoid arthritis patients Inclusion criteria

  • Patients (> 18 years) with rheumatoid arthritis ≥5 years according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
  • Patients who are receiving treatment on an outpatient basis.
  • Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.

Exclusion criteria

  • Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
  • Evidence of active malignant disease.
  • Hypo- or hyperthyroidism.
  • Hypocalcaemia.
  • Impaired renal function (eGFR <35ml/min).
  • Pregnancy. Pre-rheumatoid arthritis patients Inclusion criteria
  • Age over 18 years.
  • Anti-CCP 3 times the upper limit of the reference interval.
  • Arthralgia.
  • Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.

Exclusion criteria

  • Pregnancy.
  • Swelling of joints. Verified by clinical ultrasound.
  • Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
  • Evidence of malignant disease.
  • Hypo- or hyperthyroidism.
  • Hypocalcaemia. Healthy subjects Inclusion criteria
  • Age over 18 years.
  • No joint complaints.
  • Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.

Exclusion criteria

  • Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
  • Evidence of malignant disease.
  • Hypo- or hyperthyroidism.
  • Hypocalcaemia.
  • Impaired renal function (eGFR <35ml/min).
  • Earlier or present rheumatological disease or bone metabolic disease.
  • Positive anti-CCP.
  • Pregnancy.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：队列
  • 时间观点：预期

队列和干预

团体/队列
Rheumatoid arthritis

Patients with Rheumatoid arthritis ≥5 years according to the ACR/EULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria.

ICD-10: M059 Seropositive rheumatoid arthritis UNS, M060 Seronegative rheumatoid arthritis, M069 Rheumatoid arthritis UNS.
Pre-Rheumatoid arthritis
Patients with joint pain, but no swelling and Anti-CCP 3 times above the upper limit.
Healthy Subjects
Healthy age- and sex-matched Individuals are recruited, as a control group.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Erosion changes by HR-pQCT
大体时间：One year
Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
One year
Volumetric bone mineral density(vBMD) changes by HR-pQCT
大体时间：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.
One year
Erosion changes by HR-pQCT
大体时间：One year
Changes in bone erosions width in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
One year
Erosion changes by HR-pQCT
大体时间：One year
Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
One year

次要结果测量

结果测量
措施说明
大体时间
Radiographic erosion score
大体时间：One year
Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
One year
CTX
大体时间：one year
Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups.
one year
P1NP
大体时间：one year
Changes from baseline to one-year follow-up in Procollagen type 1 N-terminal propeptide (P1NP) in pg/mL, in the three groups.
one year
BAP
大体时间：one year
Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups.
one year
TNF-α
大体时间：one year
Changes from baseline to one-year follow-up in the Tumor necrosis factor-alfa (TNF-α) in pg/mL, in the three groups.
one year
RANK-L
大体时间：one year
Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups.
one year
OPG
大体时间：one year
Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
one year
BGLAP
大体时间：one year
Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
one year
SCL
大体时间：one year
Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
one year
Dkk-1
大体时间：one year
Changes from baseline to one-year follow-up in Dickkopf-related protein 1 (Dkk-1) in pg/mL, in the three groups.
one year
IL-1
大体时间：one year
Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups.
one year
IL-6
大体时间：one year
Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups.
one year
IL-15
大体时间：one year
Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups.
one year
IL-16
大体时间：one year
Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups.
one year
IL-17
大体时间：one year
Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups.
one year
IL-22
大体时间：one year
Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups.
one year
IL-33
大体时间：one year
Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups.
one year
CCL11
大体时间：one year
Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups.
one year
CXCL13
大体时间：one year
Changes from baseline to one-year follow-up in Chemokine (C-X-C) motif ligand (CXCL13) in pg/mL, in the three groups.
one year
TRACP 5b
大体时间：one year
Changes from baseline to one-year follow-up in Tartrate-resistant acid phosphatase 5b (TRACP 5b) in pg/mL, in the three groups.
one year
CRP
大体时间：one year
Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups.
one year
Disease Activity Score
大体时间：one year
Disease Activity Score (DAS28-CRP) [2.0-10.0]
one year
Health Assessment Questionnaire
大体时间：one year
Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
one year
VAS for pain
大体时间：one year
Visual Analog Scale(VAS) for pain [0-100mm]
one year
VAS for fatigue
大体时间：one year
Visual Analog Scale(VAS) for fatigue [0-100mm]
one year
VAS for quality of life
大体时间：one year
Visual Analog Scale(VAS) for quality of life [0-100mm]
one year

其他结果措施

结果测量
措施说明
大体时间
areal bone mineral density (aBMD)
大体时间：one year
aBMD in the lumbar spine, and the left hip by DXA, in RA patients
one year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Aarhus University Hospital

合作者

University of Aarhus

调查人员

  • 研究主任：Ellen-Margrethe Hauge, MD, PhD、Department of Rheumatology - Aarhus University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年2月15日

初级完成 (预期的)

2022年2月1日

研究完成 (预期的)

2026年12月31日

研究注册日期

首次提交

2018年1月24日

首先提交符合 QC 标准的

2018年2月5日

首次发布 (实际的)

2018年2月12日

研究记录更新

最后更新发布 (实际的)

2021年1月13日

上次提交的符合 QC 标准的更新

2021年1月12日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RACTX

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Jamaica

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅