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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Adipokines, Tocilizumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adiponectin evaluation

Arm Description

Patients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab

Outcomes

Primary Outcome Measures

Serum total adiponectin (ng/ml)

Secondary Outcome Measures

Serum high-molecular weight adiponectin (ng/ml)

Full Information

First Posted
July 19, 2016
Last Updated
February 9, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02843789
Brief Title
Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
Acronym
ADIPRAT
Official Title
Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Adipokines, Tocilizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adiponectin evaluation
Arm Type
Experimental
Arm Description
Patients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Primary Outcome Measure Information:
Title
Serum total adiponectin (ng/ml)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Serum high-molecular weight adiponectin (ng/ml)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Toussirot, Professor
Organizational Affiliation
University Hospital, Besançon, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Besançon
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32993784
Citation
Toussirot E, Marotte H, Mulleman D, Cormier G, Coury F, Gaudin P, Dernis E, Bonnet C, Damade R, Grauer JL, Abdesselam TA, Guillibert-Karras C, Liote F, Hilliquin P, Sacchi A, Wendling D, Le Goff B, Puyraveau M, Dumoulin G. Increased high molecular weight adiponectin and lean mass during tocilizumab treatment in patients with rheumatoid arthritis: a 12-month multicentre study. Arthritis Res Ther. 2020 Sep 29;22(1):224. doi: 10.1186/s13075-020-02297-7.
Results Reference
derived

Learn more about this trial

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

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