Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample.
- Who it may be relevant to
- Registry conditions: Rheumatic Diseases, Mood Disorders. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
Overview
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.
Interventions
- Other Blood sample
Blood sample (20mL) for pro-inflammatory cytokines assay
Primary outcome measures
- Severity of depressive symptoms [Time frame: 1 month after initiation of anti-TNFa therapy]
Secondary outcome measures (6)
- Evaluation of disease activity [Time frame: 3 months after initiation of anti-TNFa therapy]
- Evaluation of disease activity [Time frame: 3 months after initiation of anti-TNFa therapy]
- Evaluation of disease activity [Time frame: 3 months after initiation of anti-TNFa therapy]
- Evaluation of disease activity [Time frame: 3 months after initiation of anti-TNFa therapy]
- Evaluation of Fatigue [Time frame: 3 months after initiation of anti-TNFa therapy]
- Evaluation of Pleasure [Time frame: 3 months after initiation of anti-TNFa therapy]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- University Hospital — Besançon
Identifiers
NCT: NCT04817072 · P/2019/462