Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

NCT04817072 | Recruiting

• 1 other identifier: P/2019/462
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

TNF alpha inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluation of disease activity

  3 months after initiation of anti-TNFa therapy

• Evaluation of disease activity

  3 months after initiation of anti-TNFa therapy

• Evaluation of disease activity

  3 months after initiation of anti-TNFa therapy

• Evaluation of disease activity

  3 months after initiation of anti-TNFa therapy

• Evaluation of Fatigue

  3 months after initiation of anti-TNFa therapy

Study Arms (1)

Chronic inflammatory rheumatic disease

OTHER

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

Interventions

Blood sample OTHER

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

Chronic inflammatory rheumatic disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

University Hospital

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases; Mood Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eric Toussirot, PU-PH

  Besançon University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charline Vauchy, PhD

CONTACT

+333 81 21 88 75; cvauchy@chu-besancon.fr

Magali Nicolier-Pallandre, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: March 25, 2021
• Study Start: May 19, 2021
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)