NCT06737952

Brief Summary

This study aims to study the inflammatory response in various forms of arthritis.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
44mo left

Started May 2025

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
May 2025Dec 2029

First Submitted

Initial submission to the registry

December 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

4.6 years

First QC Date

December 11, 2024

Last Update Submit

April 8, 2025

Conditions

Keywords

ultrasound-guided synovial biopsies (UGSB)inflammatory responsesynovial biopsy

Outcome Measures

Primary Outcomes (3)

  • Grade of synovitis

    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

    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

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

arthritis patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

* Synovial tissue samples collected from inflamed joints, samples at least 6 mm in size with typical characteristics of synovium * Synovial fluid * peripheral blood

MeSH Terms

Conditions

ArthritisArthritis, RheumatoidOsteoarthritisSpondylarthritisSynovitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone Diseases

Study Officials

  • Diego Kyburz, Prof. Dr.

    Universitätsspital Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Kyburz, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 17, 2024

Study Start

May 1, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 11, 2025

Record last verified: 2025-04