Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease

Conditions
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Rheumatic Diseases, Mood Disorders

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chronic inflammatory rheumatic disease<br>Patients presenting a chronic inflammatory rheumatic disease (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis), requiring anti-TNFa therapy and with a QIDS SR-16 (QIDS-SR 16-Quick Inventory of Depressive Symptomatology-Self Reported 16 items) score between 6 and 19 | Other: Blood sample<br>* Blood sample (20mL) for pro-inflammatory cytokines assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of depressive symptoms | Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms | 1 month after initiation of anti-TNFa therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of disease activity | Evaluation with CPDAI (Composite Psoriatic Disease Activity Index) (minimum value: 0; maximum value: 15; increases with the activity of the disease) | 3 months after initiation of anti-TNFa therapy | 
| Evaluation of disease activity | Evaluation with DAS28 (Disease Activity Score 28-joint count) (minimum value: 0; maximum value: 9.4; increases with the activity of the disease) | 3 months after initiation of anti-TNFa therapy | 
| Evaluation of disease activity | Evaluation with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (minimum value: 0 (no disease activity); maximum value: 10 (very active disease)) | 3 months after initiation of anti-TNFa therapy | 
| Evaluation of disease activity | Evaluation with ASDAS (Ankylosing Spondylitis Disease Activity Score) (minimum value: 0 (no disease activity); value >3.5 between : very high disease activity) | 3 months after initiation of anti-TNFa therapy | 
| Evaluation of Fatigue | Evaluation with Functional Assessment of Chronic Illness Therapy | 3 months after initiation of anti-TNFa therapy | 
| Evaluation of Pleasure | 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. | 3 months after initiation of anti-TNFa therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TNF alpha inhibitor