Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Incidence Rate of Serious Infections
研究概览
简要总结
This prospective observational study will evaluate the long-term safety of MabThera/Rituxan (rituximab) in participants with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis. Data will be collected for a maximum of 4 years from participants initiated on MabThera/Rituxan therapy by their physician according to prescribing information.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants, >/= 18 years of age
- •Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), according to Chapel Hill Consensus Conference Definitions for MPA and American College of Rheumatology (ACR) Criteria for the Classification of GPA
- •Disease severity requiring rituximab treatment per the investigator's assessment
排除标准
- •Prior use of rituximab (except if received within 4 weeks of screening)
- •Known hypersensitivity to rituximab, to any component of the product, or to murine proteins
- •Pregnant or breastfeeding women
- •Diagnosis of Churg-Strauss syndrome
研究组 & 干预措施
Rituximab
Participants with granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
干预措施: Rituximab (Drug)
结局指标
主要结局
Incidence Rate of Serious Infections
时间窗: From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
次要结局
- Percentage of Participants With a Serious Infusion-related Reaction(From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years))
- Incidence Rate of Serious Cardiac Adverse Events(From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years))
- Incidence Rate of Serious Vascular Adverse Events(From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years))
- Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer(From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years))
- Incidence Rate of Adverse Events With Fatal Outcomes(From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years))
- Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion(From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years))
- Incidence Rate of Serious Adverse Events(From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years))
- Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab(From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years))
- Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab(From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years))