Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- treatment response
研究概览
简要总结
This is a prospective study to investigate the treatment response of Tocilizumab on patients with active chronic periaortitis (CP).
Methods: patients with a definite or possible diagnosis of CP at acute active stage were enrolled for this study and accepted Tocilizumab monotherapy for 3 months.
Endpoints: The primary endpoint is to investigate the treatment response of Tocilizumab; the secondary endpoints include the improvement of inflammatory markers, the frequency of adverse events.
详细描述
Patients enrolled received intravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months. Demographic and clinical features, laboratory findings and imaging examinations were recorded at baseline and during 3-month follow-up. Imaging improvement was converted into the ratio of perivascular soft tissues shrinkage by evaluating 2 dimensions of greatest change on computed tomography (CT) at baseline and after 3 months. Partial remission was defined as obtaining alleviation of symptoms and normalization of inflammatory markers including erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hsCRP), with shrinkage of soft tissue mass in imaging <70%. Further, complete remission was defined as normalization of inflammatory markers accompanied by shrinkage of soft tissue mass ≥70%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults ≥ 18 years of age at time of informed consent;
- •meet clinical diagnostic criteria including (1) imaging findings show perivascular soft tissue density mass surrounding thoracic aorta, abdominal aorta or iliac arteries; (2) histopathological findings show fibrous tissue with chronic inflammatory infiltrate comprised of lymphocytes, plasma cells and macrophages (Neutrophils and granulomas are rare). Patients who satisfied (1) but without histopathological examination were perceived as possible CP;
- •at active stage: clinical symptoms or organ involvement; a higher level of ESR and CRP than normal;
排除标准
- •Secondary forms of CP related to drugs, infections, malignancies, Erdheim-Chester disease or other autoimmune diseases were excluded.
- •Combined with other autoimmune diseases.
- •Known immunodeficiency disorder.
- •Pregnancy, lactation, or planning to become pregnant within 6 months of the test.
- •Positive test for, or prior treatment for, hepatitis B or HIV infection. A positive test for hepatitis B is detection of hepatitis B surface antigen (HBsAg) or HBV-DNA.
- •Evidence of active tuberculosis (TB), including Chest X-ray and PPD.
- •Severe abnormal liver function or cardiac insufficiency.
- •Any reason the investigator think that should not attend this trial.
研究组 & 干预措施
Tocilizumab monotherapy
Patients with a definite or possible diagnosis of CP at acute active stage were enrolled for this study. Clinical diagnostic criteria consist of: (1) imaging findings show perivascular soft tissue density mass surrounding thoracic aorta, abdominal aorta or iliac arteries; (2) histopathological findings show fibrous tissue with chronic inflammatory infiltrate comprised of lymphocytes, plasma cells and macrophages (Neutrophils and granulomas are rare). Patients who satisfied (1) but without histopathological examination were perceived as possible CP. Secondary forms of CP related to drugs, infections, malignancies, Erdheim-Chester disease or other autoimmune diseases were excluded.
Patients enrolled received intravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months.
干预措施: Tocilizumab monotherapy (Drug)
结局指标
主要结局
treatment response
时间窗: three months
the rate of partial remission and complete remission after 3-month TCZ monotherapy
次要结局
- the frequency of treatment related adverse events(three months)
- the improvement of inflammatory markers(three months)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital