Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease (EMOTION)

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Mood Disorders; Rheumatic Diseases

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04817072

P/2019/462

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Chronic inflammatory rheumatic disease

Other group

Description:

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

Treatment:

Other: Blood sample