Arthritis, RheumatoidBERANCT04645381
Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology
An observational study of Arthritis, Rheumatoid, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The aim of this study is to describe macro- and micro anatomical structures, including investigating vessels running in osseous pores in finger joints from participants with rheumatoid arthritis (RA) using histology and different imaging modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 9 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2020to Nov 2035
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants with RA are recruited in conjunction with a routine visit at the Department of Orthopedic Surgery at Aarhus University Hospital or at the Regional Hospital Holstebro for assessment of surgical indication for joint replacement surgery on MCP joints by a specialist in orthopedic surgery.
Who may be able to join
- Age > 18 years
- Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
- Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of OA in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).
Who cannot join
- Unable to give written informed consent.
- Active malignant disease, hypercalcemia, poor kidney function (estimated glomerular filtration rate < 35 mL/min), untreated hypo-/hyperthyroidism, pregnancy or wish thereof, previously fracture/dislocation of the investigated joint or metal prosthesis in joints of the investigated hand.
- Bone sample will be excluded from analysis, if the following is present:
- Bone not adequate for analysis (fractured bone samples).
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, Central Region of Denmark, 8200
Regional Hospital Holstebro
Holstebro, Central Region of Denmark, 7500
About this study
The aim of this study is to describe macro- and micro anatomical structures, including investigating vessels running in osseous pores in finger joints from participants with rheumatoid arthritis (RA) using histology and different imaging modalities. The perspectives are to increase understanding of the macro- and micro anatomic basis for bone erosions in RA, and possibly to provide new insights to the monitoring of patients with RA.
Read the detailed description
This study is a descriptive, cross-sectional pilot study. The trial subjects will have their hands imaged by conventional radiography. The 2nd and 3rd digit metacarpophalangeal (MCP) joint will be scanned by high-resolution peripheral quantitative computed tomography (HR-pQCT). Patients with RA (n = 10) will be included and bone samples from MCP joints analyzed using microcomputed tomography (µCT) and histology.
ELIGIBILITY CRITERIA
Inclusion criteria:
- Age > 18 years.
- Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
- Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of osteoarthrosis (OA) in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, High-resolution peripheral quantitative computed tomography, Radiography, Micro computed tomography, Histology
- 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 |
|---|---|---|
| Participants with RA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcortical vessels and pores.
To identify and describe transcortical vessels and pores at the bare area in MCP joints from RA patients and describe the location, number, and compare intra- and extra-articularly by histology, μCT, and HR-pQCT.
Measured: within 24 weeks after inclusion
Secondary outcomes (2)
The bare area
To identify and describe the bare area in MCP joints from RA patients macroscopically, with imaging (HR-pQCT, conventional X-ray, μCT), and histology.
Measured: within 24 weeks after inclusion
Bone erosions
To identify bone erosions by conventional X-ray, μCT, and HR-pQCT and assess inflammatory infiltrates using histology in RA patients.
Measured: within 24 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Nov 2020
- Primary completion1 May 2026
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of AarhusThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Ellen-Margrethe Hauge, Professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645381
- Sponsor's protocol ID
- 675-897-002
- Acronym
- BERA
- Status last verified
- May 2026
- First submitted
- 20 Nov 2020
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41571324
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology
- ClinicalTrials.gov ID
- NCT04645381
- Acronym / sponsor ID
- BERA / 675-897-002
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, High-resolution peripheral quantitative computed tomography, Radiography, Micro computed tomography, Histology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- Nov 2035 (estimated)
- First posted
- 27 Nov 2020 (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.
The aim of this study is to describe macro- and micro anatomical structures, including investigating vessels running in osseous pores in finger joints from participants with rheumatoid arthritis (RA) using histology and different imaging modalities. The perspectives are to increase understanding of the macro- and micro anatomic basis for bone erosions in RA, and possibly to provide new insights to the monitoring of patients with RA.
Detailed description
This study is a descriptive, cross-sectional pilot study. The trial subjects will have their hands imaged by conventional radiography. The 2nd and 3rd digit metacarpophalangeal (MCP) joint will be scanned by high-resolution peripheral quantitative computed tomography (HR-pQCT). Patients with RA (n = 10) will be included and bone samples from MCP joints analyzed using microcomputed tomography (µCT) and histology.
ELIGIBILITY CRITERIA
Inclusion criteria:
- Age > 18 years.
- Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
- Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of osteoarthrosis (OA) in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with RA | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with RA are recruited in conjunction with a routine visit at the Department of Orthopedic Surgery at Aarhus University Hospital or at the Regional Hospital Holstebro for assessment of surgical indication for joint replacement surgery on MCP joints by a specialist in orthopedic surgery.
Key inclusion criteria (3 listed)
- Age > 18 years
- Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
- Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of OA in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).
Key exclusion criteria (4 listed)
- Unable to give written informed consent.
- Active malignant disease, hypercalcemia, poor kidney function (estimated glomerular filtration rate < 35 mL/min), untreated hypo-/hyperthyroidism, pregnancy or wish thereof, previously fracture/dislocation of the investigated joint or metal prosthesis in joints of the investigated hand.
- Bone not adequate for analysis (fractured bone samples).
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
Transcortical vessels and pores.
Time frame: within 24 weeks after inclusion
To identify and describe transcortical vessels and pores at the bare area in MCP joints from RA patients and describe the location, number, and compare intra- and extra-articularly by histology, μCT, and HR-pQCT.
2 secondary outcomes
The bare area
Time frame: within 24 weeks after inclusion
Bone erosions
Time frame: within 24 weeks after inclusion
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 4 May 2026.
- 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ellen-Margrethe Hauge, Professor study director
Aarhus University Hospital
2 sites 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 University of Aarhus at 2 sites 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Transcortical vessels and pores. (time frame: within 24 weeks after inclusion). 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 NCT04645381, which also lists 1 linked publication.
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 4 May 2026.