Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-09

Study Completion Date

2018-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthritis,Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tocilizumab treated

Tocilizumab

Intervention Type DRUG

Anti-TNF treated

Adalimumab

Intervention Type DRUG

Interventions

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Tocilizumab

Intervention Type DRUG

Adalimumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No