Evaluation Effects of Treatment With IL-6R Inhibitor on Clinical Response and Biomarkers in Patients With Rheumatoid Arthritis (RA) Not Responding to DMARDs and/or a First Biological Agent.
Phase 4
- Conditions
- Rheumatoid Arthritis (RA)
- Registration Number
- NCT01835613
- Lead Sponsor
- Osservatorio Epidemiologico GISEA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Disease Activity Score (DAS-44) 12 months
- Secondary Outcome Measures
Name Time Method Simplified Disease Activity Index (SDAI);Biomarkers Measures SDAI at 3-6-12-18 months Biomarkers Measures Biomarkers Measures at 3-6-12-18 months 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:
Trial Locations
- Locations (1)
Università Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Università Cattolica del Sacro Cuore🇮🇹Roma, Italy