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Exploratory study to assess the Fibroblast Activation Protein (FAP) expression signatures compared to cellular signature of synovial tissue in patients with rheumatoid arthritis – PIX Tissue I

Exploratory study to assess the Fibroblast Activation Protein (FAP) expression signatures compared to cellular signature of synovial tissue in patients with rheumatoid arthritis – PIX Tissue I - PiXTissue I

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00040052
Enrollment
30
Registered
2026-04-28
Start date
2025-11-05
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M06.9

Interventions

Group 1: Patients with rheumatoid arthritis (RA), that are inculded in another trial in which one of their joints receives a synovial biopsy at the start of a new treatment will be included. For this

Sponsors

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Ready and able to give informed consent - Starting a new DMARD therapy - Receiving a synovial biopsy in the course of another trial protocol (Vote number 2191/2019 or 1107/2024 from the ehtical committee of the Medical University of Vienna) - Evidence of active arthritis, prooven by one ore more swollen joint - Ready and able to undergo a FAPi PET/CT scan

Exclusion criteria

Exclusion criteria: - Patients with severe medical conditions (e. g. end stage renal disease) - Poor tolerance of venipuncture or failure to establish adequate venous access for the necessary blood sampling during the study period - Active infection - Pregnant or nursing women - Other serious acute or chronic medical or psychiatric conditions, or laboratory abnormalities, which, in the investigator’s judgement, would pose an excessive risk in connection with the trial or which, in the investigator’s judgement, would render the patient unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Correlation between FAPi uptake (mean, maximal and peak standardised uptake value) and cell modules and molecular signatures from synovial biopsy at baseline.

Secondary

MeasureTime frame
Correlation between changes in FAPi and response to therapy (baseline to week 16).

Countries

Austria

Contacts

Public ContactPeter Mandl

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie

peter.mandl@medunwien.ac.at+4314040043000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026