NCT07000890

Rheumatoid Arthritis Synovial Tissue Biopsy Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients (n=50) included in this trial will be diagnosed with RA according to the ACR/EULAR 2010 classification criteria. They will be eligible for standard-of-care therapy using TNF blockers, because they have active disease despite previous administration of two conventional DMARDs (including methotrexate) for a period of at least 3 months each. Disease activity at study entry (before initiation of TNF blockade) and at 12 weeks will be assessed using DAS28-CRP (composite score that integrates numbers of tender and swollen joints, serum CRP concentrations, and patient's evaluation of disease activity on a visual analogic scale) and EULAR response criteria. All treatments other than TNF blockade will be stable for at least 4 weeks before study entry, and for the whole duration of the study (4 months after initiation of TNF blockade). All clinical assessments will be performed by the investigators. Efficacy will be assessed according to the ACR/EULAR core set of response (DAS28-CRP, CDAI, SDAI, HAQ) of TNFi and JAKi in period 2 for non-responders to TNFi.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-23
• Primary completion: 2023-11-07
• Completion: 2024-12-13
• First posted: 2025-06-03
• Last updated: 2025-06-03

Locations

1 site across 1 country: Belgium