Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

NCT02963402 | Completed

• 1 other identifier: IIBSP-TOC-2016-09
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis,Rheumatoid

Outcome Measures

Primary Outcomes (2)

• Treg phenotype

  Baseline to 6 months change

• ATP (adenosine triphosphate)

  Baseline to 6 months change

Study Arms (2)

Tocilizumab treated

Drug: Tocilizumab

Anti-TNF treated

Drug: Adalimumab

Interventions

Tocilizumab DRUG

Tocilizumab treated

Adalimumab DRUG

Anti-TNF treated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Insitut de Recerca Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 15, 2016
• Study Start: November 9, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

ES (1)