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

Arthritis, Rheumatoid Clinical Trial

— BERA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04645381
• Other study ID #: 675-897-002
• Status: Active, not recruiting
• Start date: November 1, 2020
• Est. completion date: November 2035

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: November 2035
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Region Of Denmark
Denmark	Regional Hospital Holstebro	Holstebro	Central Region Of Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microarchitecture	Microarchitecture in the cortical and trabecular bone compartment by HR-pQCT and µCT in RA patients.	within 24 weeks after inclusion
Primary	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	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
Secondary	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