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

Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) 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.

Study Overview

• Status: Recruiting
• Conditions: Mood Disorders; Rheumatic Diseases
• Intervention / Treatment: Other: Blood sample

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charline Vauchy, PhD; Phone Number: +333 81 21 88 75; Email: cvauchy@chu-besancon.fr
• Study Contact Backup: Name: Magali Nicolier-Pallandre, PhD

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • University Hospital
    • Contact: Charline VAUCHY
    • Principal Investigator: Eric Toussirot, PU-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Blood sample; Blood sample (20mL) for pro-inflammatory cytokines assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of disease activity	Evaluation with CPDAI (Composite Psoriatic Disease Activity Index) (minimum value: 0; maximum value: 15; increases with the activity of the disease)	3 months after initiation of anti-TNFa therapy
Evaluation of disease activity	Evaluation with DAS28 (Disease Activity Score 28-joint count) (minimum value: 0; maximum value: 9.4; increases with the activity of the disease)	3 months after initiation of anti-TNFa therapy
Evaluation of disease activity	Evaluation with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (minimum value: 0 (no disease activity); maximum value: 10 (very active disease))	3 months after initiation of anti-TNFa therapy
Evaluation of disease activity	Evaluation with ASDAS (Ankylosing Spondylitis Disease Activity Score) (minimum value: 0 (no disease activity); value >3.5 between : very high disease activity)	3 months after initiation of anti-TNFa therapy
Evaluation of Fatigue	Evaluation with Functional Assessment of Chronic Illness Therapy	3 months after initiation of anti-TNFa therapy
Evaluation of Pleasure	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.	3 months after initiation of anti-TNFa therapy

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Eric Toussirot, PU-PH, Besançon University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: TNF alpha inhibitor
• Additional Relevant MeSH Terms: Mental Disorders; Musculoskeletal Diseases; Connective Tissue Diseases; Mood Disorders; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: P/2019/462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No