Mood Disorders, Rheumatic Diseases
Conditions
Keywords
TNF alpha inhibitor
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.
Interventions
OTHERBlood sample
Blood sample (20mL) for pro-inflammatory cytokines assay
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of depressive symptoms | 1 month after initiation of anti-TNFa therapy | Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of disease activity | 3 months after initiation of anti-TNFa therapy | Evaluation with CPDAI (Composite Psoriatic Disease Activity Index) (minimum value: 0; maximum value: 15; increases with the activity of the disease) |
| Evaluation of Fatigue | 3 months after initiation of anti-TNFa therapy | Evaluation with Functional Assessment of Chronic Illness Therapy |
| Evaluation of Pleasure | 3 months after initiation of anti-TNFa therapy | Evaluation with Snaith-Hamilton pleasure scale (minimum value: 0 (no disease activity); maximum value: 14 (very active disease)). A higher total SHAPS score indicated higher levels of anhedonia. |
Countries
France
Contacts
Primary ContactCharline Vauchy, PhD
Backup ContactMagali Nicolier-Pallandre, PhD
Outcome results
None listed