NCT07000890Completed
Rheumatoid Arthritis Synovial Tissue Biopsy Study
Source: ClinicalTrials.gov · Last updated 3 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 20 Jun 2022
- Start date
- 23 Jun 2020
- Primary completion date
- 7 Nov 2023
- Lead sponsor
- Université Catholique de Louvain
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07000890
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 23 Jun 2020 to the primary completion date, 7 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Age
- Women of child-bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy
Other
- Women who are pregnant or breastfeeding
- Subjects who are unable to accept and perform the synovial biopsy procedure.
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.