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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Erosion changes by HR-pQCT | 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 | 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 | 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 | Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic erosion score | Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups. | One year |
| CTX | Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups. |
| Measure | Description | Time Frame |
|---|---|---|
| areal bone mineral density (aBMD) | aBMD in the lumbar spine, and the left hip by DXA, in RA patients | one year |
Rheumatoid arthritis patients Inclusion criteria
Exclusion criteria
Exclusion criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ellen-Margrethe Hauge, MD, PhD | Department of Rheumatology - Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology, Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41571324 | Derived | Therkildsen J, Klose-Jensen R, Langdahl B, Bruel A, Thomsen JS, Moger C, Stilling M, Keller KK, Hauge EM. Mapping the bare area and transcortical pores in finger joints: co-location with bone erosions in rheumatoid arthritis. RMD Open. 2026 Jan 22;12(1):e006371. doi: 10.1136/rmdopen-2025-006371. | |
| 39547428 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2018 | Jan 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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A research biobank for blood samples will be established for the project.
| one year |
| P1NP | 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 | 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 | 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 | Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups. | one year |
| OPG | Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups. | one year |
| BGLAP | Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups. | one year |
| SCL | Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups. | one year |
| Dkk-1 | 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 | Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups. | one year |
| IL-6 | Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups. | one year |
| IL-15 | Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups. | one year |
| IL-16 | Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups. | one year |
| IL-17 | Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups. | one year |
| IL-22 | Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups. | one year |
| IL-33 | Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups. | one year |
| CCL11 | Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups. | one year |
| CXCL13 | 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 | 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 | 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 | Disease Activity Score (DAS28-CRP) [2.0-10.0] | one year |
| Health Assessment Questionnaire | Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score] | one year |
| VAS for pain | Visual Analog Scale(VAS) for pain [0-100mm] | one year |
| VAS for fatigue | Visual Analog Scale(VAS) for fatigue [0-100mm] | one year |
| VAS for quality of life | Visual Analog Scale(VAS) for quality of life [0-100mm] | one year |
| Therkildsen J, Klose-Jensen R, Hanel M, Langdahl BL, Thomsen JS, Manske SL, Keller KK, Hauge EM. Detecting new erosions in rheumatoid arthritis over one year - Radiography and high-resolution computed tomography of finger joints. Joint Bone Spine. 2025 Jan;92(1):105812. doi: 10.1016/j.jbspin.2024.105812. Epub 2024 Nov 14. |
| 38749001 | Derived | Therkildsen J, Klose-Jensen R, Hanel M, Langdahl BL, Thygesen J, Thomsen JS, Manske SL, Keller KK, Hauge EM. Erosive progression by high-resolution peripheral quantitative computed tomography and conventional radiography in rheumatoid arthritis. Rheumatology (Oxford). 2025 Mar 1;64(3):1092-1101. doi: 10.1093/rheumatology/keae281. |
| 34015091 | Derived | Klose-Jensen R, Therkildsen J, Blavnsfeldt AG, Langdahl BL, Zejden A, Thygesen J, Keller KK, Hauge EM. Diagnostic accuracy of high-resolution peripheral quantitative computed tomography and X-ray for classifying erosive rheumatoid arthritis. Rheumatology (Oxford). 2022 Mar 2;61(3):963-973. doi: 10.1093/rheumatology/keab446. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |