Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF

NCT02475486

Last updated date
Study Location
Chu Saint-Etienne
Saint-etienne, , 42055, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

:

- RA diagnosis according to ACR/EULAR 2010

- RA with low disease activity according to DAS28 < 3.2

- Written consent obtained

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

:


- Other diagnosis than RA


- Depression known


- Hypertension treated or not,


- Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy,


- Pregnant or breastfeeding women,


- Inability to go two consecutive days at the North hospital for the delivery and return
of the Vista02 device

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Advanced Information
Descriptive Information
Brief Title  ICMJE Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
Official Title  ICMJE Role of the Sympathetic Nervous System (ANS) Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF (Tumor Necrosis Factor) - a Monocentric Cross-sectional Study
Brief Summary

Despite the large therapeutic arsenal available since one decade allowing a strong reduction of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher prevalence of non-inflammatory pain than general population. Fatigue is a real major problem due to 50% of patients considered it as severe.

This dissociation between disease activity and fatigue level suggests that fatigue is multifactorial. No consistent explanations for fatigue are currently available.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Device: VistaO2
ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
Study Arms  ICMJE
  • high fatigue
    Measure of ANS by VistaO2 device in Rheumatoid arthritis (RA) patients with low disease activity according to DAS28 <3.2 with visual analog scale of fatigue is > 5
    Intervention: Device: VistaO2
  • low fatigue
    Measure of ANS by VistaO2 device in Rheumatoid arthritis (RA) patients with low disease activity according to DAS28 <3.2 with visual analog scale of fatigue is < or equal to 5
    Intervention: Device: VistaO2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2015)
100
Actual Study Completion Date  ICMJE October 8, 2018
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • RA diagnosis according to ACR/EULAR 2010
  • RA with low disease activity according to DAS28 < 3.2
  • Written consent obtained

Exclusion Criteria :

  • Other diagnosis than RA
  • Depression known
  • Hypertension treated or not,
  • Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy,
  • Pregnant or breastfeeding women,
  • Inability to go two consecutive days at the North hospital for the delivery and return of the Vista02 device
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02475486
Other Study ID Numbers  ICMJE 1508054
2015-A00655-44 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Hubert Marotte, PUPHCHU SAINT-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP