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NCT Number: NCT04645381

Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Central Region of Denmark, Denmark

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

RA Participants:

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 OA in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. The bare area

    Time frame: within 24 weeks after inclusion

    To identify and describe the bare area in MCP joints from RA patients macroscopically, with imaging (HR-pQCT, conventional X-ray, μCT), and histology.

  2. Bone erosions

    Time frame: within 24 weeks after inclusion

    To identify bone erosions by conventional X-ray, μCT, and HR-pQCT and assess inflammatory infiltrates using histology in RA patients.

Other outcomes

  1. Microarchitecture

    Time frame: within 24 weeks after inclusion

    Microarchitecture in the cortical and trabecular bone compartment by HR-pQCT and μCT in RA patients.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Acronym: BERA

Important dates

Study start
2020
Primary completion
2026
Study completion
2035
First posted
Nov 27, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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