ArthritisNCT06737952
Cellular and Molecular Analysis of Synovial Tissue of Patients With Arthritis
An observational study of Arthritis and Arthritis, Rheumatoid, run by University Hospital, Basel, Switzerland.
Trial summary
This study aims to study the inflammatory response in various forms of arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Arthritis, Rheumatoid, Osteoarthritis
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2029
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: arthritis patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to study the inflammatory response in various forms of arthritis.
Read the 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.
- Conditions
- Arthritis, Arthritis, Rheumatoid, Osteoarthritis, Spondyloarthritis, Synovitis
- Keywords
- ultrasound-guided synovial biopsies (UGSB), inflammatory response, synovial biopsy
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Osteoarthritis, Spondylarthritis, Synovitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of synovitis
assessed by the Krenn score in the hematoxylin and eosin staining (Score 0-3, 0=normal, 3=severe)
Measured: 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
Measured: 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.
Measured: immediately after collection to study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study startMay 2025 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Kyburz, Prof. Dr., Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737952
- Sponsor's protocol ID
- 2024-02011; mu24kyburz
- Status last verified
- Apr 2025
- First submitted
- 11 Dec 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular and Molecular Analysis of Synovial Tissue of Patients With Arthritis
- ClinicalTrials.gov ID
- NCT06737952
- Acronym / sponsor ID
- 2024-02011; mu24kyburz
- Conditions
- Arthritis, Arthritis, Rheumatoid, Osteoarthritis, Spondyloarthritis, Synovitis
- Keywords
- ultrasound-guided synovial biopsies (UGSB), inflammatory response, synovial biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to study the inflammatory response in various forms of arthritis.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- arthritis patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
Related trials for Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Kyburz, Prof. Dr. principal investigator
Universitätsspital Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Arthritis, Rheumatoid, run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Kyburz, Prof. Dr. (+41 61 328 74 81, diego.kyburz@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of synovitis (time frame: immediately after collection to study completion, up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.