NCT04645381

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
113mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Nov 2020Nov 2035

Study Start

First participant enrolled

November 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2035

Expected
Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

5.5 years

First QC Date

November 20, 2020

Last Update Submit

May 1, 2026

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid ArthritisHigh-resolution peripheral quantitative computed tomographyRadiographyMicro computed tomographyHistology

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 24 weeks after inclusion

Secondary Outcomes (2)

  • The bare area

    within 24 weeks after inclusion

  • Bone erosions

    within 24 weeks after inclusion

Other Outcomes (1)

  • Microarchitecture

    within 24 weeks after inclusion

Study Arms (1)

Participants with RA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, Central Region of Denmark, 8200, Denmark

Location

Regional Hospital Holstebro

Holstebro, Central Region of Denmark, 7500, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 41571324DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bone samples.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ellen-Margrethe Hauge, Professor

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 27, 2020

Study Start

November 1, 2020

Primary Completion

May 1, 2026

Study Completion (Estimated)

November 1, 2035

Last Updated

May 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)