NCT04817072 Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease
| NCT ID | NCT04817072 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Besancon |
| Condition | Rheumatic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2021-05-19 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2021-05-19 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Eric Toussirot, PU-PH
PRINCIPAL INVESTIGATOR
Besançon University Hospital
Frequently Asked Questions
Who can join the NCT04817072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Rheumatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04817072 currently recruiting?
Yes, NCT04817072 is actively recruiting participants. Contact the research team at cvauchy@chu-besancon.fr for enrollment information.
Where is the NCT04817072 trial being conducted?
This trial is being conducted at Besançon, France.
Who is sponsoring the NCT04817072 clinical trial?
NCT04817072 is sponsored by Centre Hospitalier Universitaire de Besancon. The principal investigator is Eric Toussirot, PU-PH at Besançon University Hospital. The trial plans to enroll 108 participants.