Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

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

Status: Completed

Conditions: Arthritis,Rheumatoid

Treatments: Drug: Adalimumab; Drug: Tocilizumab

Study type: Observational

Funder types: Other

Identifiers

NCT02963402

IIBSP-TOC-2016-09

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

Tocilizumab treated

Treatment:

Drug: Tocilizumab

Anti-TNF treated

Treatment:

Drug: Adalimumab