Arthritis, RheumatoidRACTXNCT03429426
Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray
An observational study of Arthritis, Rheumatoid, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 625 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 27Show fewer
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Rheumatology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: 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.
Read the 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)
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, High-resolution peripheral quantitative computed tomography, Radiography
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One year
Secondary outcomes (26)
Radiographic erosion score
Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
Measured: One year
CTX
Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups.
Measured: 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.
Measured: one year
BAP
Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups.
Measured: 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.
Measured: one year
RANK-L
Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups.
Measured: one year
OPG
Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
Measured: one year
BGLAP
Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
Measured: one year
SCL
Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
Measured: 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.
Measured: one year
IL-1
Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups.
Measured: one year
IL-6
Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups.
Measured: one year
IL-15
Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups.
Measured: one year
IL-16
Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups.
Measured: one year
IL-17
Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups.
Measured: one year
IL-22
Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups.
Measured: one year
IL-33
Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups.
Measured: one year
CCL11
Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups.
Measured: 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.
Measured: 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.
Measured: one year
CRP
Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups.
Measured: one year
Disease Activity Score
Disease Activity Score (DAS28-CRP) [2.0-10.0]
Measured: one year
Health Assessment Questionnaire
Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
Measured: one year
VAS for pain
Visual Analog Scale(VAS) for pain [0-100mm]
Measured: one year
VAS for fatigue
Visual Analog Scale(VAS) for fatigue [0-100mm]
Measured: one year
VAS for quality of life
Visual Analog Scale(VAS) for quality of life [0-100mm]
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Feb 2018
- Primary completion1 Feb 2022 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Rasmus Klose-Jensen, Aarhus University Hospital
- Investigators
- Ellen-Margrethe Hauge, MD, PhD, Study director, Department of Rheumatology - Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429426
- Sponsor's protocol ID
- RACTX
- Acronym
- RACTX
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41571324Therkildsen 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.
PubMed 39547428Therkildsen 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.
PubMed 38749001Klose-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.
PubMed 34015091
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Bone Erosion Determination and Progression in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray
- ClinicalTrials.gov ID
- NCT03429426
- Acronym / sponsor ID
- RACTX / RACTX
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, High-resolution peripheral quantitative computed tomography, Radiography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Erosion changes by HR-pQCT
Time frame: One year
Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
Volumetric bone mineral density(vBMD) changes by HR-pQCT
Time frame: 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
Time frame: One year
Changes in bone erosions width in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
Erosion changes by HR-pQCT
Time frame: One year
Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
26 secondary outcomes
Radiographic erosion score
Time frame: One year
CTX
Time frame: one year
P1NP
Time frame: one year
BAP
Time frame: one year
TNF-α
Time frame: one year
RANK-L
Time frame: one year
OPG
Time frame: one year
BGLAP
Time frame: one year
SCL
Time frame: one year
Dkk-1
Time frame: one year
IL-1
Time frame: one year
IL-6
Time frame: one year
IL-15
Time frame: one year
IL-16
Time frame: one year
IL-17
Time frame: one year
IL-22
Time frame: one year
IL-33
Time frame: one year
CCL11
Time frame: one year
CXCL13
Time frame: one year
TRACP 5b
Time frame: one year
CRP
Time frame: one year
Disease Activity Score
Time frame: one year
Health Assessment Questionnaire
Time frame: one year
VAS for pain
Time frame: one year
VAS for fatigue
Time frame: one year
VAS for quality of life
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 41571324Therkildsen 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.
- Derived from this study: PubMed 39547428Therkildsen 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.
- Derived from this study: PubMed 38749001Therkildsen 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.
- Derived from this study: PubMed 34015091Klose-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen-Margrethe Hauge, MD, PhD study director
Department of Rheumatology - Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erosion changes by HR-pQCT (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429426, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.