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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis, Rheumatoid

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Professor; Phone Number: 7845 0000; Email: AarhusUniversitetshospital@auh.rm.dk

Study Locations

• Denmark
  • Central Region Of Denmark
    • Aarhus, Central Region Of Denmark, Denmark, 8200
      • Recruiting
      • Aarhus University Hospital
      • Contact: PROFESSOR
    • Holstebro, Central Region Of Denmark, Denmark, 7500
      • Not yet recruiting
      • Regional Hospital Holstebro
      • Contact: PROFESSOR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with RA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	within 24 weeks after inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microarchitecture	Microarchitecture in the cortical and trabecular bone compartment by HR-pQCT and μCT in RA patients.	within 24 weeks after inclusion

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Study Director: Ellen-Margrethe Hauge, Professor, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2035

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Histology; High-resolution peripheral quantitative computed tomography; Radiography; Micro computed tomography
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 675-897-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No