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Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02963402
Enrollment
35
Registered
2016-11-15
Start date
2016-11-09
Completion date
2018-10-01
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis,Rheumatoid

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.

Interventions

DRUGTocilizumab
DRUGAdalimumab

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Treg phenotypeBaseline to 6 months change
ATP (adenosine triphosphate)Baseline to 6 months change

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026