NCT02899871已完成不适用
Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Diagnosis of joint pain
研究概览
简要总结
IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females over the age of 18 years at the time of inclusion
- •Patients with IBD (Crohn's disease or ulcerative colitis), diagnosed by a set of compatible clinical (chronic diarrhoea, haematochezia, anoperineal lesions, etc.), laboratory, histological and endoscopic arguments. Patients will be included regardless of the severity of their disease, its clinical course, the type of lesions, and the presence or absence of associated manifestations.
- •Patients treated with anti-TNF: infliximab or adalimumab.
- •Informed patients not refusing to participate.
- •Patients covered by French national health insurance.
排除标准
- •Patients under the age of 18 years at the time of inclusion.
- •Patients previously treated with anti-TNF, but no longer treated with anti-TNF at the time of inclusion.
- •Protected majors (under permanent or temporary guardianship).
结局指标
主要结局
Diagnosis of joint pain
时间窗: 1 year
presence or absence : The diagnosis of joint pain will be established by a rheumatologist and completed: * If necessary, by a clinically guided radiological assessment (plain x-rays, joint ultrasound, bone and joint MRI). * serum assays of the anti-TNF administered, as well as screening for associated antibodies.
次要结局
未报告次要终点
研究者
研究点 (1)
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