The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) \<2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.
Università Cattolica del Sacro Cuore
Roma, Italy
RECRUITINGDisease Activity Score (DAS-44)
Time frame: 12 months
Simplified Disease Activity Index (SDAI);Biomarkers Measures
Time frame: SDAI at 3-6-12-18 months
Biomarkers Measures
Evaluation by ELISA of the levels of the following biomarkers: IL-8, MCP-1, Chemerin, IL-1α, IL-1β, IL-17, IL-23, TGFβ1, IL-10, BAFF.in the plasma:
Time frame: Biomarkers Measures at 3-6-12-18 months
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