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Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy (ADIPRAT)

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ClinicalTrials.gov Identifier: NCT02843789
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
The aim of this study is to analyze the variation of adiponectinemia and its molecular forms in RA patients receiving tocilizumab therapy.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Tocilizumab Phase 4

Detailed Description:

Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with cardiovascular morbidity. Tocilizumab (TCZ), a monoclonal antibody against the interleukin-6 receptor is an effective new biotherapy for the treatment of RA. This treatment is associated with increased LDL and HDL-cholesterol lipid parameters. Adipokines are adipose tissue-specific secreted molecules, which have many functions such as regulation of appetite, blood glucose or immune response. Among the adipokines, adiponectin exerts beneficial effects on the cardiovascular system. Patients with RA also exhibit body composition changes, including an increase in abdominal visceral fat. The impact of tocilizumab therapy in RA patients on adipokines and body composition is not known.

This project aims to explore the evolution of circulating adiponectin and other adipokines during tocilizumab therapy in RA. Body composition and its variations under tocilizumab therapy will also be analyzed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
Study Start Date : March 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: Adiponectin evaluation
Patients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab
Drug: Tocilizumab



Primary Outcome Measures :
  1. Serum total adiponectin (ng/ml) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Serum high-molecular weight adiponectin (ng/ml) [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of RA and requiring Tocilizumab therapy
  • Subject has provided written informed consent

Exclusion Criteria:

  • Corticosteroid therapy (10 mg/day of prednisone or equivalent)
  • Pregnant or lactating women
  • Uncontrolled type 1 or type 2 diabetes
  • Uncontrolled dyslipidemia
  • Elevated transaminases (> three times higher than the normal range)
  • History of diverticulitis or intestinal perforation
  • Tocilizumab contraindications: Severe or active infections, Hypersensitivity to the active substance or to any of the excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843789


Locations
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France
University Hospital
Besançon, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Eric Toussirot, Professor University Hospital, Besançon, France
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02843789    
Other Study ID Numbers: P/2011/118
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Adipokines
Tocilizumab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases