Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)
2021년 1월 12일 업데이트: 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.
연구 개요
상태
상태
초대로 등록
정황
정황
상세 설명
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)
연구 유형
연구 유형
관찰
등록 (예상)
등록
625
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Aarhus, 덴마크, 8000
- Department of Rheumatology, Aarhus University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
해당 없음
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
그룹/코호트 수
3
코호트 및 개입
그룹/코호트그룹/코호트 |
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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. |
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Pre-Rheumatoid arthritis
Patients with joint pain, but no swelling and Anti-CCP 3 times above the upper limit.
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Healthy Subjects
Healthy age- and sex-matched Individuals are recruited, as a control group.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Erosion changes by HR-pQCT
기간: One year
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Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Volumetric bone mineral density(vBMD) changes by HR-pQCT
기간: One year
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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.
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One year
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Erosion changes by HR-pQCT
기간: One year
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Changes in bone erosions width in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Erosion changes by HR-pQCT
기간: One year
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Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Radiographic erosion score
기간: One year
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Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
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One year
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CTX
기간: one year
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Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups.
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one year
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P1NP
기간: one year
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Changes from baseline to one-year follow-up in Procollagen type 1 N-terminal propeptide (P1NP) in pg/mL, in the three groups.
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one year
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BAP
기간: one year
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Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups.
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one year
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TNF-α
기간: one year
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Changes from baseline to one-year follow-up in the Tumor necrosis factor-alfa (TNF-α) in pg/mL, in the three groups.
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one year
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RANK-L
기간: one year
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Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups.
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one year
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OPG
기간: one year
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Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
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one year
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BGLAP
기간: one year
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Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
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one year
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SCL
기간: one year
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Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
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one year
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Dkk-1
기간: one year
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Changes from baseline to one-year follow-up in Dickkopf-related protein 1 (Dkk-1) in pg/mL, in the three groups.
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one year
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IL-1
기간: one year
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Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups.
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one year
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IL-6
기간: one year
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Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups.
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one year
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IL-15
기간: one year
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Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups.
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one year
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IL-16
기간: one year
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Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups.
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one year
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IL-17
기간: one year
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Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups.
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one year
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IL-22
기간: one year
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Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups.
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one year
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IL-33
기간: one year
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Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups.
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one year
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CCL11
기간: one year
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Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups.
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one year
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CXCL13
기간: one year
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Changes from baseline to one-year follow-up in Chemokine (C-X-C) motif ligand (CXCL13) in pg/mL, in the three groups.
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one year
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TRACP 5b
기간: one year
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Changes from baseline to one-year follow-up in Tartrate-resistant acid phosphatase 5b (TRACP 5b) in pg/mL, in the three groups.
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one year
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CRP
기간: one year
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Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups.
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one year
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Disease Activity Score
기간: one year
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Disease Activity Score (DAS28-CRP) [2.0-10.0]
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one year
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Health Assessment Questionnaire
기간: one year
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Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
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one year
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VAS for pain
기간: one year
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Visual Analog Scale(VAS) for pain [0-100mm]
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one year
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VAS for fatigue
기간: one year
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Visual Analog Scale(VAS) for fatigue [0-100mm]
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one year
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VAS for quality of life
기간: one year
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Visual Analog Scale(VAS) for quality of life [0-100mm]
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one year
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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areal bone mineral density (aBMD)
기간: one year
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aBMD in the lumbar spine, and the left hip by DXA, in RA patients
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one year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 책임자: Ellen-Margrethe Hauge, MD, PhD, Department of Rheumatology - Aarhus University Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2018년 2월 15일
기본 완료 (예상)
기본 완료
2022년 2월 1일
연구 완료 (예상)
연구 완료
2026년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2018년 1월 24일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2018년 2월 5일
처음 게시됨 (실제)
처음 게시됨
2018년 2월 12일
연구 기록 업데이트
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2021년 1월 13일
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2021년 1월 12일
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추가 정보
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기타 연구 ID 번호
기타 연구 ID 번호
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
관절염, 류마티스에 대한 임상 시험
-
NCT07174102모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)