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

Primary Purpose

Rheumatic Diseases, Mood Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatic Diseases focused on measuring TNF alpha inhibitor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Chronic inflammatory rheumatic disease

Arm Description

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

Outcomes

Primary Outcome Measures

Severity of depressive symptoms
Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms

Secondary Outcome Measures

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)
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)
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))
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)
Evaluation of Fatigue
Evaluation with Functional Assessment of Chronic Illness 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.

Full Information

First Posted
January 29, 2021
Last Updated
April 5, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT04817072
Brief Title
Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease
Acronym
EMOTION
Official Title
Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases, Mood Disorders
Keywords
TNF alpha inhibitor

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic inflammatory rheumatic disease
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood sample (20mL) for pro-inflammatory cytokines assay
Primary Outcome Measure Information:
Title
Severity of depressive symptoms
Description
Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms
Time Frame
1 month after initiation of anti-TNFa therapy
Secondary Outcome Measure Information:
Title
Evaluation of disease activity
Description
Evaluation with CPDAI (Composite Psoriatic Disease Activity Index) (minimum value: 0; maximum value: 15; increases with the activity of the disease)
Time Frame
3 months after initiation of anti-TNFa therapy
Title
Evaluation of disease activity
Description
Evaluation with DAS28 (Disease Activity Score 28-joint count) (minimum value: 0; maximum value: 9.4; increases with the activity of the disease)
Time Frame
3 months after initiation of anti-TNFa therapy
Title
Evaluation of disease activity
Description
Evaluation with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (minimum value: 0 (no disease activity); maximum value: 10 (very active disease))
Time Frame
3 months after initiation of anti-TNFa therapy
Title
Evaluation of disease activity
Description
Evaluation with ASDAS (Ankylosing Spondylitis Disease Activity Score) (minimum value: 0 (no disease activity); value >3.5 between : very high disease activity)
Time Frame
3 months after initiation of anti-TNFa therapy
Title
Evaluation of Fatigue
Description
Evaluation with Functional Assessment of Chronic Illness Therapy
Time Frame
3 months after initiation of anti-TNFa therapy
Title
Evaluation of Pleasure
Description
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.
Time Frame
3 months after initiation of anti-TNFa therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charline Vauchy, PhD
Phone
+333 81 21 88 75
Email
cvauchy@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Magali Nicolier-Pallandre, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Toussirot, PU-PH
Organizational Affiliation
Besançon University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charline VAUCHY
First Name & Middle Initial & Last Name & Degree
Eric Toussirot, PU-PH

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

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