Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau35 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Arthritis,Rheumatoid

Interventions

TocilizumabDRUG

AdalimumabDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Insitut de Recerca Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Outcomes

Primary Outcomes

Treg phenotype

Time frame: Baseline to 6 months change

ATP (adenosine triphosphate)

Time frame: Baseline to 6 months change

Data from ClinicalTrials.gov

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