Clinical trial NCT04817072: Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease
Official title: Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatic Diseases
Mood Disorders
Keywords: TNF alpha inhibitor
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 ; ≤ 80)
* Patient with rheumatoid arthritis (RA) according to the ACR 2010 criteria, axial or peripheral spondyloarthritis (SpA) according to ASAS criteria, ankylosing spondylitis (AS) according to the New York criteria or psoriatic arthritis (PsA) according to CASPAR criteria
* Signature of informed consent
* Affiliation to a French social security or receiving such a scheme

Exclusion Criteria:

* Patient having previously received anti-TNFα treatment
* Patient with previously diagnosed depressive or psychiatric pathology and / or receiving anti-depressant treatment
* Subjects with limited legal capacity.
* Subjects judged by the investigator to be unlikely to comply with study procedures
* Subjects with no social security coverage.
* Pregnant women.
* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.

Primary outcomes:
measure: Severity of depressive symptoms
timeFrame: 1 month after initiation of anti-TNFa therapy
Secondary outcomes:
measure: Evaluation of disease activity
timeFrame: 3 months after initiation of anti-TNFa therapy
measure: Evaluation of disease activity
timeFrame: 3 months after initiation of anti-TNFa therapy
measure: Evaluation of disease activity
timeFrame: 3 months after initiation of anti-TNFa therapy
measure: Evaluation of disease activity
timeFrame: 3 months after initiation of anti-TNFa therapy
measure: Evaluation of Fatigue
timeFrame: 3 months after initiation of anti-TNFa therapy
measure: Evaluation of Pleasure
timeFrame: 3 months after initiation of anti-TNFa therapy
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital
Study officials:
affiliation: Besançon University Hospital
name: Eric Toussirot, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: