RHEUMATOID ARTHRITIS MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: KEVZARA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SARILUMAB
CAS Number: 1189541-98-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conc
Sponsors
IDIVAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients = 18 years diagnosed with active RA: DAS28>3.2 and levels of CRP of at least 1 mg/dl. - Naïve to biologic DMARDs (bDMARDs) or refractory to a single bDMARD different from anti- IL-6 agents. - Only patients with plaques assessed by carotid US will be included in the PET/CT study. Plaques will be detected by US (for this purpose of at least 1.5 mm). - Patients who are candidates for sarilumab according to summary of product characteristics (SmPC). - Patients must sign informed consent. 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with previous history of CV events. - Patients with history of diabetes or chronic renal failure. - Patients with an absolute neutrophil count (ANC) less than 2 x 109/L. - Patients with platelet count below 150 x 103/µL. - Patients with elevated transaminases, ALT or AST greater than 1.5 x ULN. - Patients with an active infection, including localized infections. - Patients who are not candidates for sarilumab according to SmPC. - Patients enrolled in other clinical trial or research project. - Patients who do not sign the informed consent. -Women who are pregnant or breastfeeding, or those of child-bearing who are not using an effective method of contraception
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in 18F-fluorodeoxyglucose (18F-FDG) PET/CT uptake at the aortic wall (inflammatory component) over 6 months of treatment with Sarilumab. - Change in 18F-sodium fluoride (18F-NaF) PET/CT uptake at the aortic wall (mineralization) over 6 months of treatment with Sarilumab. - Clinical improvement of the disease after onset of treatment with Sarilumab measured by disease activity score (DAS)28, clinical disease activity index (CDAI), simple disease activity index (SDAI) and routine laboratory measures of inflammation, as C-reactive protein (CRP) levels. - Reduction of insulin resistance (IR) and improvement of insulin sensitivity, modulation of lipid profile and changes in mRNA expression and serum levels of adipokines, metabolic syndrome (MetS)-related biomarkers and endothelial cell activation and inflammation biomarkers.;Timepoint(s) of evaluation of this end point: BASAL, 3 AND 6 MONTHS | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess by PET/CT the effect of Sarilumab in the carotid atheroma plaque (effect on the inflammatory component as well as on mineralization) in patients with rheumatoid arthritis over 6 months of Sarilumab treatment.;Secondary Objective: -To determine the change in 18F-FDG PET/CT uptake at the aortic wall (inflammatory component) over 6 months of Sarilumab treatment. - To assess the change in 18F-FNa PET/CT uptake at the aortic wall (mineralization) over 6 months of Sarilumab treatment. -To analyze the correlation with clinical improvement of the disease, by using well-defined methods to determine disease activity in RA (including DAS28, CDAI, SDAI, erythrocyte sedimentation rate (ESR), CRP) over 6 months of Sarilumab treatment. -To evaluate the change in adipokines, biomarkers of endothelial cell activation and inflammation, as well as biomarkers related to metabolic syndrome (MetS) over 6 months of Sarilumab treatment.;Primary end point(s): Effect of Sarilumab over 6 months of treatment, in the carotid atheroma plaque (effect on the inflammatory component as well as on mineralization) evaluated by PET/CT in patients diagnosed with RA.;Timepoint(s) of evaluation of this end point: BASAL AND 6 MONTHS | — |
Countries
Spain
Contacts
Public ContactMar García Saiz
IDIVAL
Outcome results
None listed