Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, High-resolution peripheral quantitative computed tomography, Radiography
Brief summary
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.
Detailed description
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)
Interventions
None listed
Sponsors
University of Aarhus
Aarhus University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric bone mineral density(vBMD) changes by HR-pQCT | 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. |
| Erosion changes by HR-pQCT | One year | Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CTX | one year | Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups. |
| P1NP | 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. |
| BAP | one year | Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups. |
| TNF-α | 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. |
| RANK-L | one year | Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups. |
| OPG | one year | Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups. |
| BGLAP | one year | Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups. |
| SCL | one year | Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups. |
| Dkk-1 | one year | Changes from baseline to one-year follow-up in Dickkopf-related protein 1 (Dkk-1) in pg/mL, in the three groups. |
| IL-1 | one year | Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups. |
| IL-6 | one year | Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups. |
| IL-15 | one year | Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups. |
| IL-17 | one year | Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups. |
| IL-22 | one year | Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups. |
| IL-33 | one year | Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups. |
| CCL11 | one year | Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups. |
| CXCL13 | 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. |
| TRACP 5b | 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. |
| CRP | one year | Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups. |
| Disease Activity Score | one year | Disease Activity Score (DAS28-CRP) \[2.0-10.0\] |
| Health Assessment Questionnaire | one year | Health Assessment Questionnaire (HAQ) \[0-3 HAQ Total Score\] |
| VAS for pain | one year | Visual Analog Scale(VAS) for pain \[0-100mm\] |
| VAS for fatigue | one year | Visual Analog Scale(VAS) for fatigue \[0-100mm\] |
| VAS for quality of life | one year | Visual Analog Scale(VAS) for quality of life \[0-100mm\] |
| IL-16 | one year | Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups. |
| Radiographic erosion score | One year | Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| areal bone mineral density (aBMD) | one year | aBMD in the lumbar spine, and the left hip by DXA, in RA patients |
Countries
Denmark
Outcome results
None listed