Mood changes during TNF-alpha blocker treatment for chronic inflammatory rheumatic diseases
Official title: Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
Run by Centre Hospitalier Universitaire de Besancon · NCT04817072 · Data updated 2026-11-12
This will test whether starting TNF-alpha blocker treatment improves anxiety or depression symptoms in adults with rheumatoid arthritis, spondyloarthritis, ankylosing spondylitis, or psoriatic arthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Locations | 1 site (Besançon) |
| Status | Recruiting |
| Started | May 19, 2021 |
| Main results expected | November 2025 |
| Study ends | May 2026 |
| Registry record updated | July 9, 2025 |
| Trial ID | NCT04817072 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with rheumatoid arthritis, spondyloarthritis (axial or peripheral), ankylosing spondylitis, or psoriatic arthritis who have never received anti-TNF therapy, have no prior diagnosed psychiatric disorder, can consent, and have French social security are ideal candidates.
✕Probably not a fit
Patients who previously received anti-TNF treatment, have a diagnosed depressive or other psychiatric disorder, are pregnant, lack French social security, or cannot comply with procedures are unlikely to benefit or are ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The EMOTION protocol follows adults with chronic inflammatory rheumatic diseases who are starting TNF-alpha blocker therapy, collecting blood samples and clinical mood measures before and during treatment. Researchers will measure plasma inflammatory markers (including TNF-alpha) and correlate changes in these biomarkers with standardized anxiety and depression scales over time. Patients with prior anti-TNF exposure or preexisting psychiatric diagnoses are excluded to focus on treatment-related mood changes. The study is conducted at the University Hospital of Besançon and requires French social security coverage.
Why it matters
Potential benefit: If successful, the findings could show that TNF-alpha blockers improve mood in people with these rheumatic diseases, helping clinicians consider inflammation-targeted approaches for anxiety or depression.
How similar studies have gone: Previous research has reported reductions in depressive symptoms following anti-TNF treatment in some patients with inflammatory diseases, but results are inconsistent and mechanisms are not fully established.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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University Hospital
Besançon, France Recruiting
Study contacts
- Principal investigator: Eric Toussirot, PU-PH — Besançon University Hospital
- Study coordinator: Charline Vauchy, PhD
- Email: cvauchy@chu-besancon.fr
- Phone: +333 81 21 88 75
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.