Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
ADIPRAT
1 other identifier
interventional
109
1 country
1
Brief Summary
The aim of this study is to analyze the variation of adiponectinemia and its molecular forms in RA patients receiving tocilizumab therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedFebruary 13, 2018
February 1, 2018
4.7 years
July 19, 2016
February 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum total adiponectin (ng/ml)
12 months
Secondary Outcomes (1)
Serum high-molecular weight adiponectin (ng/ml)
12 months
Study Arms (1)
Adiponectin evaluation
EXPERIMENTALPatients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab
Interventions
Eligibility Criteria
You may qualify if:
- Patients with a diagnosis of RA and requiring Tocilizumab therapy
- Subject has provided written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Besançon, France
Related Publications (1)
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.
PMID: 32993784DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Toussirot, Professor
University Hospital, Besançon, France
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2016
First Posted
July 26, 2016
Study Start
March 1, 2013
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
February 13, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share