Cellular and Molecular Analysis of Synovial Tissue of Patients With Arthritis

April 8, 2025 updated by: University Hospital, Basel, Switzerland
This study aims to study the inflammatory response in various forms of arthritis.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Arthritis, a significant heald burden is characterized by joint inflammation that severely impacts patients' quality of live. Despite advancements in treatment, many individuals with conditions like rheumatoid arthritis (RA), osteoarthritis (OA), and spondyloarthritis (SpA) do not achieve satisfactory outcomes, underscoring the need for more precise therapeutic strategies.

The project aims to characterize the inflammatory response in various form of arthritis by collecting and analyzing synovial tissue-the connective tissue lining joints. Biopsies will be collected through ultrasound-guided biopsies (UGSB), a minimally invasive and well-tolerated procedure. Presence of immune and stromal cells in the tissue, their interactions, and their relationship to clinical symptoms are characterized by histological and molecular methods. By comparing these features across different forms of arthritis, the study aims to identify molecular pathways and biomarkers that distinguish these diseases and their subtypes. The study hopes to contribute to a broader understanding of arthritis pathophysiology, ultimately translating into novel therapeutic targets and tailored clinical strategies.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

arthritis patients

Description

Inclusion Criteria:

  • Age >18 years
  • Clinically relevant arthritis in one or more joints as assessed by the treating rheumatologist, including RA, SpA, connective tissue disease and OA.

Exclusion Criteria:

  • Known allergies to local anesthetics
  • Family history of bleeding, history of increased bleeding tendency or prolonged bleeding, current treatment with oral anticoagulants or platelet aggregation inhibitors; Quick < 65%, international normalised ratio (INR) ≥ 1.3, thrombocyte count < 100'000/μl, activated partial thromboplastin time (aPTT) > 37 sec
  • Inability or insufficient knowledge of project language to understand the information given in the informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of synovitis
Time Frame: immediately after collection to study completion, up to 5 years
assessed by the Krenn score in the hematoxylin and eosin staining (Score 0-3, 0=normal, 3=severe)
immediately after collection to study completion, up to 5 years
classification pathotypes
Time Frame: immediately after collection to study completion, up to 5 years
immunohistochemical staining with cell type specific markers including CD15, CD68, CD3, CD20, CD138 of the collected tissues from different arthritis subtypes
immediately after collection to study completion, up to 5 years
comparing transcriptomic signature
Time Frame: immediately after collection to study completion, up to 5 years
single-cell RNA sequencing of collected tissues from different arthritis subtypes to identify disease specific biomarkers.
immediately after collection to study completion, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Diego Kyburz, Prof. Dr., Universitätsspital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-02011; mu24kyburz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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