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

NCT02475486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-06-26

No results posted yet for this study

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

Interventions

DEVICE

VistaO2

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Hubert Marotte, PUPH · CHU SAINT-ETIENNE

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-25
Primary Completion
2018-10-08
Completion
2018-10-08

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475486 on ClinicalTrials.gov