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OpenTrials
Completed

NCT Number: NCT02963402

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.

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Key information

Conditions

Arthritis,Rheumatoid Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Insitut de Recerca Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

Adalimumab

Drug

Primary outcomes

  1. Treg phenotype

    Time frame: Baseline to 6 months change

  2. ATP (adenosine triphosphate)

    Time frame: Baseline to 6 months change

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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