Status:
COMPLETED
Rheumatoid Arthritis Synovial Tissue Biopsy Study
Lead Sponsor:
Université Catholique de Louvain
Collaborating Sponsors:
Galapagos NV
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 addit...
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, bec...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07000890
Start Date
June 23 2020
End Date
December 13 2024
Last Update
June 3 2025
Active Locations (1)
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1
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1200