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

• ClinicalTrials.gov Identifier: NCT02475486
• Recruitment Status: Completed
• First Posted: June 18, 2015
• Last Update Posted: June 26, 2019
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborator: Pfizer
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Tracking Information

• First Submitted Date: June 16, 2015
• First Posted Date: June 18, 2015
• Last Update Posted Date: June 26, 2019
• Actual Study Start Date: February 25, 2016
• Actual Primary Completion Date: October 8, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 16, 2015)

Ratio low/high frequencies of power spectral density of R-R intervals [ Time Frame: day1 ]

Comparison of Ratio low/high frequencies of power spectral density of R-R intervals between RA patients with low fatigue and RA patients with high fatigue. Ratio low/high frequencies of power spectral density of R-R is measured by VistaO2 device.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 20, 2018)

• Number of sleep apnea syndrome [ Time Frame: day 1 ]
  Comparison of Number of sleep apnea syndrome between between RA patients with low fatigue and RA patients with high fatigue. sleep apnea syndrome is measured by VistaO2 device.
• Standard deviation of all R-R intervals (SDNN) [ Time Frame: day 1 ]
  Comparison of Standard deviation of all R-R intervals (SDNN) between RA patients with low fatigue and RA patients with high fatigue. Standard deviation of all R-R intervals (SDNN) is measured by VistaO2 device.
• Total Power spectral density (PSD) [ Time Frame: day 1 ]
  Comparison of Total Power spectral density (PSD) between RA patients with low fatigue and RA patients with high fatigue. Total Power spectral density (PSD) is measured by VistaO2 device.
• PSD of Lower Frequencies [ Time Frame: day 1 ]
  Comparison of PSD of Lower Frequencies between RA patients with low fatigue and RA patients with high fatigue. PSD of Lower Frequencies is measured by VistaO2 device.
• PSD of High Frequencies [ Time Frame: day 1 ]
  Comparison of PSD of High Frequencies between RA patients with low fatigue and RA patients with high fatigue. PSD of High Frequencies is measured by VistaO2 device.
• normalized value of the High and Low frequencies [ Time Frame: day 1 ]
  Comparison of normalized value of the High and Low frequencies between RA patients with low fatigue and RA patients with high fatigue. normalized value of the High and Low frequencies is measured by VistaO2 device.
• Physical activity [ Time Frame: day 1 ]
  Comparison of physical activity between RA patients with low fatigue and RA patients with high fatigue. Physical activity is measured by IPAQ score.
• quality of sleep [ Time Frame: day 1 ]
  Comparison of quality of sleep between RA patients with low fatigue and RA patients with high fatigue. Quality of sleep is measured by PSQI score.
• depression [ Time Frame: day 1 ]
  Comparison of depression level between RA patients with low fatigue and RA patients with high fatigue. Depression is measured by HAD, BDI and HDRS scales.
• Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals [ Time Frame: day 1 ]
  fatigue is measured with a visual analogic scale

Original Secondary Outcome Measures (submitted: June 16, 2015)

• Number of sleep apnea syndrome [ Time Frame: day 1 ]
  Comparison of Number of sleep apnea syndrome between between RA patients with low fatigue and RA patients with high fatigue. sleep apnea syndrome is measured by VistaO2 device.
• Standard deviation of all R-R intervals (SDNN) [ Time Frame: day 1 ]
  Comparison of Standard deviation of all R-R intervals (SDNN) between RA patients with low fatigue and RA patients with high fatigue. Standard deviation of all R-R intervals (SDNN) is measured by VistaO2 device.
• Total Power spectral density (PSD) [ Time Frame: day 1 ]
  Comparison of Total Power spectral density (PSD) between RA patients with low fatigue and RA patients with high fatigue. Total Power spectral density (PSD) is measured by VistaO2 device.
• PSD of Lower Frequencies [ Time Frame: day 1 ]
  Comparison of PSD of Lower Frequencies between RA patients with low fatigue and RA patients with high fatigue. PSD of Lower Frequencies is measured by VistaO2 device.
• PSD of High Frequencies [ Time Frame: day 1 ]
  Comparison of PSD of High Frequencies between RA patients with low fatigue and RA patients with high fatigue. PSD of High Frequencies is measured by VistaO2 device.
• normalized value of the High and Low frequencies [ Time Frame: day 1 ]
  Comparison of normalized value of the High and Low frequencies between RA patients with low fatigue and RA patients with high fatigue. normalized value of the High and Low frequencies is measured by VistaO2 device.
• Physical activity [ Time Frame: day 1 ]
  Comparison of physical activity between RA patients with low fatigue and RA patients with high fatigue. Physical activity is measured by IPAQ score.
• quality of sleep [ Time Frame: day 1 ]
  Comparison of quality of sleep between RA patients with low fatigue and RA patients with high fatigue. Quality of sleep is measured by PSQI score.
• depression [ Time Frame: day 1 ]
  Comparison of depression level between RA patients with low fatigue and RA patients with high fatigue. Depression is measured by HAD, BDI and HDRS scales.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Rheumatoid Arthritis

Intervention

Device: VistaO2

ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2018): 50
• Original Estimated Enrollment (submitted: June 16, 2015): 100
• Actual Study Completion Date: October 8, 2018
• Actual Primary Completion Date: October 8, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 30 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02475486
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• Study Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Pfizer

Investigators

• Principal Investigator: Hubert Marotte, PUPH; CHU SAINT-Etienne

• PRS Account: Centre Hospitalier Universitaire de Saint Etienne
• Verification Date: June 2019