Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

November 12, 2018 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Insitut de Recerca Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

AR patients treated with tocilizumab in monotherapy or treated with adalimumab as control.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tocilizumab treated
Drug: Tocilizumab
Anti-TNF treated
Drug: Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treg phenotype
Time Frame: Baseline to 6 months change
Baseline to 6 months change
ATP (adenosine triphosphate)
Time Frame: Baseline to 6 months change
Baseline to 6 months change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TOC-2016-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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