Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
NCT02475486
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:
- RA diagnosis according to ACR/EULAR 2010
- RA with low disease activity according to DAS28 < 3.2
- Written consent obtained
:
- 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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Descriptive Information | |||||
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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 |
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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 | 50 | ||||
Original Estimated Enrollment ICMJE | 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 :
Exclusion Criteria :
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | ||||
Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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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 |