Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Arthritis,Rheumatoid Clinical Trial

Official title:

Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963402
• Other study ID #: IIBSP-TOC-2016-09
• Status: Completed
• Start date: November 9, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Arthritis,Rheumatoid

Intervention

Drug:
• Tocilizumab

• Adalimumab

Locations

Country	Name	City	State
Spain	Insitut de Recerca Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treg phenotype		Baseline to 6 months change
Primary	ATP (adenosine triphosphate)		Baseline to 6 months change