Rheumatoid Arthritis Synovial Tissue Biopsy Study

NCT07000890 | Completed

• 1 other identifier: 2020/28AVR/252
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Primary resistance to TNF blockade in synovium

  Identification of novel mechanisms associated with primary resistance to TNF blockade in synovial biopsies using single cell RNASeq analyses

  6 months

Study Arms (1)

Synovial biopsy

EXPERIMENTAL

Assessment of the effects of TNF blockade on cells isolated from RA synovial tissue prior to and 12 weeks after initiation of therapy.

Diagnostic Test: Synovial Biopsy

Interventions

Synovial Biopsy DIAGNOSTIC_TEST

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.

Synovial biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females (not nursing and not pregnant) at least 18 years of age. Women of child-bearing potential are eligible if they are practicing effective contraceptive measures.
• Subjects must meet the criteria of the 2010 EULAR/ACR criteria for the diagnosis of rheumatoid arthritis
• Subjects must have a disease activity as defined by a tender joint count \> 4, swollen joint count \> 4 from 68 joints and a DAS28-CRP \>3.7. (This value is the cut off level to obtain a reimbursement for bDMARDs in Belgium).
• Subjects were treated with MTX 15 mg a week (or 7.5 mg in case of poor tolerance) for at least 3 months.
• Subjects must be naive to TNF inhibitors (Adalimumab, Etanercept, Infliximab, Certolizumab, Golimumab) and other b- or tsDMARDs (Abatacept, Tocilizumab, Rituximab and JAK inhibitors)

You may not qualify if:

• Women of child-bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy
• Women who are pregnant or breastfeeding
• Subjects with a history of cancer within the last five years (other than nonmelanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing.
• Subjects with any serious bacterial infection and at risk for tuberculosis (TB).
• Subjects who are unable to accept and perform the synovial biopsy procedure.

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Galapagos NV: collaborator

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Patrick Durez

  UCLouvain - IREC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 3, 2025
• Study Start: June 23, 2020
• Primary Completion: November 7, 2023
• Study Completion: December 13, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)