Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)
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.
調査の概要
状態
条件
詳細な説明
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)
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Aarhus、デンマーク、8000
- Department of Rheumatology, Aarhus University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Erosion changes by HR-pQCT
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Radiographic erosion score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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areal bone mineral density (aBMD)
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Ellen-Margrethe Hauge, MD, PhD、Department of Rheumatology - Aarhus University Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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