Medical condition – Rheumatoid Arthritis MedDRA version: 21.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Kevzara
Product Name: Kevzara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SARILUMAB
CAS Number: 1189541-98-7
Concentration unit: mg milligram(s)
Sponsors
Cliniques universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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. 2) Subjects must meet the criteria of the 2010 EULAR/ACR criteria for the diagnosis of 1. rheumatoid arthritis 3) Subjects must have a disease activity as defined by a tender joint count of > 4, swollen joint count of > 4 from 68 joints and a DAS28-CRP >3.7.(This value is the cut off level to obtain a reimbursement for biologics in Belgium). 4) Subjects must be treated with a TNF BioDMARD since 3 months on a background stable dose of MTX 5) Subjects must be naive to non TNF BioDMARDs (Abatacept, Tocilizumab, Rituximab and JAK inhibitor) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid 2. pregnancy or Women who are pregnant or breastfeeding 1) Subjects with a history of cancer within the last five years (other than nonmelanoma 3. skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. 2) Subjects with any serious bacterial infection and at risk for tuberculosis (TB). 3) Unable to accept and perform the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients ;Secondary Objective: The secondary endpoints of the study are as follows: To assess the efficacy and safety and tolerability of Sarilumab compared to TNF BioDMARD prolongation in active RA on a background therapy with MTX over 3 months of treatment. At week 12, the patients treated with a TNF agent will be switched to Sarilumab. ACR 20, 50 and EULAR response at week 12 will be the primary objectives To evaluate MRI RAMRIS score. To analyse incidence and severity of AEs, lab test abnormalities and vital signs according to GCP guidelines and SUSAR reporting. ;Primary end point(s): To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients ;Timepoint(s) of evaluation of this end point: synovial biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the efficacy and safety and tolerability of Sarilumab ;Timepoint(s) of evaluation of this end point: Sarilumab will be compared to TNF BioDMARD prolongation in active RA on a background therapy with MTX over 3 months of treatment | — |
Countries
Belgium
Contacts
Public ContactGuichet académique
CTC
Outcome results
None listed