Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Severity of depressive symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Severity of depressive symptoms
时间窗: 1 month after initiation of anti-TNFa therapy
Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms
次要结局
- Evaluation of Fatigue(3 months after initiation of anti-TNFa therapy)
- Evaluation of Pleasure(3 months after initiation of anti-TNFa therapy)
- Evaluation of disease activity(3 months after initiation of anti-TNFa therapy)