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

NCT02475486 | Completed

• 2 other identifiers: 15080542015-A00655-44
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; sympathetic nervous system; SNA; fatigue

Outcome Measures

Primary Outcomes (1)

• Ratio low/high frequencies of power spectral density of R-R intervals

  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.

  day1

Secondary Outcomes (10)

• Number of sleep apnea syndrome

  day 1

• Standard deviation of all R-R intervals (SDNN)

  day 1

• Total Power spectral density (PSD)

  day 1

• PSD of Lower Frequencies

  day 1

• PSD of High Frequencies

  day 1

Study Arms (2)

high fatigue

OTHER

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

Device: VistaO2

low fatigue

OTHER

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

Device: VistaO2

Interventions

VistaO2 DEVICE

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

high fatigue; low fatigue

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Pfizer: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fatigue

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hubert Marotte, PUPH

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 18, 2015
• Study Start: February 25, 2016
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)