Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04817072

Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Rheumatic Diseases Connective Tissue Diseases Mental Disorders Mood Disorders Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Besançon, 25000, France

Location status: Recruiting

Location contact

Charline VAUCHY

CONTACT

Eric Toussirot, PU-PH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

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

Primary outcomes

  1. Severity of depressive symptoms

    Time frame: 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 outcomes

  1. Evaluation of disease activity

    Time frame: 3 months after initiation of anti-TNFa therapy

    Evaluation with CPDAI (Composite Psoriatic Disease Activity Index) (minimum value: 0; maximum value: 15; increases with the activity of the disease)

  2. Evaluation of disease activity

    Time frame: 3 months after initiation of anti-TNFa therapy

    Evaluation with DAS28 (Disease Activity Score 28-joint count) (minimum value: 0; maximum value: 9.4; increases with the activity of the disease)

  3. Evaluation of disease activity

    Time frame: 3 months after initiation of anti-TNFa therapy

    Evaluation with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (minimum value: 0 (no disease activity); maximum value: 10 (very active disease))

  4. Evaluation of disease activity

    Time frame: 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)

  5. Evaluation of Fatigue

    Time frame: 3 months after initiation of anti-TNFa therapy

    Evaluation with Functional Assessment of Chronic Illness Therapy

  6. Evaluation of Pleasure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Charline Vauchy, PhD

CONTACT

[email protected]

+333 81 21 88 75

Magali Nicolier-Pallandre, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: EMOTION

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 25, 2021
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.