Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

NCT ID: NCT04817072

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2026-05-31

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.

Conditions

Rheumatic Diseases; Mood Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Chronic inflammatory rheumatic disease

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

Group Type: OTHER

Blood sample

Intervention Type: OTHER

Blood sample (20mL) for pro-inflammatory cytokines assay

Interventions

Blood sample

Blood sample (20mL) for pro-inflammatory cytokines assay

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Toussirot, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Besançon University Hospital

Locations

University Hospital

Besançon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Charline Vauchy, PhD

Role: CONTACT

cvauchy@chu-besancon.fr

+333 81 21 88 75

Magali Nicolier-Pallandre, PhD

Role: CONTACT

Facility Contacts

Charline VAUCHY

Role: primary

Other Identifiers

P/2019/462

Identifier Type: -

Identifier Source: org_study_id