Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Besancon
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Blood sample
Other interventionBlood sample (20mL) for pro-inflammatory cytokines assay
Treatment groups
108 Participants
are divided into 1 treatment groupGroup A: Chronic inflammatory rheumatic diseaseOther 1 intervention
Trial outcomes
Primary outcomes
1
Severity of depressive symptoms
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 therapySecondary outcomes
1
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)
Time frame
3 months after initiation of anti-TNFa therapy2
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)
Time frame
3 months after initiation of anti-TNFa therapy3
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))
Time frame
3 months after initiation of anti-TNFa therapy4
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)
Time frame
3 months after initiation of anti-TNFa therapySponsors and contacts
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Source ClinicalTrials.gov