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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04817072
Collaborator
(none)
108
Enrollment
1
Location
1
Arm
39.5
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
Actual Study Start Date :
May 19, 2021
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Evaluation of disease activity [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 [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 [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 [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 [3 months after initiation of anti-TNFa therapy]

    Evaluation with Functional Assessment of Chronic Illness Therapy

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Besançon France 25000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Eric Toussirot, PU-PH, Besançon University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04817072
Other Study ID Numbers:
  • P/2019/462
First Posted:
Mar 25, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Besancon
TNF alpha inhibitor
Additional relevant MeSH terms:
Rheumatic Diseases
Collagen Diseases
Mood Disorders

Study Results

No Results Posted as of Apr 8, 2022