Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab
- Registration Number
- NCT02963402
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
We can speculate that the best responders to tocilizumab should have multiple related elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play its beneficial role. The study of these elements and its pathways could help identify the best responders to tocilizumab treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Patients of all sexes, aged ≥ 18 years.
- RA Patients (according to ACR / EULAR criteria 2010) of moderate to severe activity (DAS 28> 3.2 or SDAI> 11), and 6 months or more of evolution, starting treatment with ACTEMRA (tocilizumab) or with an anti-TNF, according to the product data.
- Patients with body weight ≤ 150 kg.
- Patients who have received written information about the study and gave their informed consent to participate in the study
Exclusion Criteria
- Patients with a history of autoimmune disease or inflammatory joint disease other than RA.
- Patients treated with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is greater) before starting treatment with tocilizumab
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tocilizumab treated Tocilizumab - Anti-TNF treated Adalimumab -
- Primary Outcome Measures
Name Time Method Treg phenotype Baseline to 6 months change ATP (adenosine triphosphate) Baseline to 6 months change
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Insitut de Recerca Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain