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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Device: VistaO2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02475486

2015-A00655-44 (Other Identifier)

1508054

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

high fatigue

Other group

Description:

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

Treatment:

Device: VistaO2

low fatigue

Other group

Description:

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

Treatment:

Device: VistaO2