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Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

F

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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