Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

Not Applicable

Recruiting

• Conditions: Mood Disorders; Rheumatic Diseases
• Interventions: Other: Blood sample

• Registration Number: NCT04817072
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-25
• Study Start: 2021-05-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-08
• Primary Completion: 2024-05
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic inflammatory rheumatic disease	Blood sample	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of disease activity	3 months after initiation of anti-TNFa therapy	Evaluation with ASDAS (Ankylosing Spondylitis Disease Activity Score) (minimum value: 0 (no disease activity); value \>3.5 between : very high disease activity)
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.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Besançon, France