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Rheumatoid Arthritis Synovial Tissue Biopsy Study

NCT07000890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-06-03

No results posted yet for this study

Summary

In this proof-of-concept study, the investigators intend to collect synovial biopsies from MTX-resistant RA patients prior to and 12 weeks after initiation of TNF-blocking therapy (period 1). In addition to conventional histological and immunohistochemistry characterization of the samples, single cell RNASeq studies will be performed, with a particular focus on synovial T cells and fibroblasts. Clinical response to TNF blocking therapies will be assessed using validated measurements, which will result in the identification of novel mechanisms and markers of resistance to TNF inhibition in MTX-resistant RA patients.

Conditions

Interventions

DIAGNOSTIC_TEST

Synovial Biopsy

Synovial tissue and blood samples will be collected and processed for bulk and scRNAseq; serum, plasma, DNA, RNA and PBMCs as per below flow chart. Biomarker exploratory analysis will be performed.

Sponsors & Collaborators

  • Galapagos NV

    collaborator INDUSTRY

  • Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Patrick Durez · UCLouvain - IREC

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2023-11-07
Completion
2024-12-13

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07000890 on ClinicalTrials.gov