NCT01095393已完成不适用
National Data Bank for Rheumatic Disease (NDB) Registry Study of Safety in Rheumatoid Arthritis (RA) Patients Treated With Certolizumab Pegol (CZP; Cimzia®) and Non-biologic Disease-modifying Antirheumatic Drug (DMARD) Therapies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 12,500
- 主要终点
- Number of participants with lymphoma
研究概览
简要总结
Observational registry to assess the longer-term risk of serious infections and malignancies reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as compared to non-biologic DMARD-treated controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 6 months
排除标准
- 未提供
结局指标
主要结局
Number of participants with lymphoma
时间窗: 6 years
Number of participants with lymphoma during the observational period (up to 6 years)
次要结局
- Number of participants with serious infections(6 years)
- Number of participants with non-lymphoma malignancies(6 years)
- Number of participants with cardiovascular events(6 years)
- Number of participants with thromboembolic events(6 years)
研究者
相似试验
招募中
不适用
CHronic Nonbacterial Osteomyelitis International RegistryChronic Nonbacterial OsteomyelitisChronic Recurrent Multifocal OsteomyelitisNCT04725422Seattle Children's Hospital2,000
招募中
不适用
Met Non Small Cell Cancer Registry (MOMENT)CancerNCT05376891EMD Serono Research & Development Institute, Inc.700
已完成
不适用
A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast CancerLocally Advanced Breast CancerMetastatic Breast CancerNCT02595762Hoffmann-La Roche110
招募中
不适用
Lysosomal Acid Lipase (LAL) Deficiency RegistryLysosomal Acid Lipase DeficiencyCholesterol Ester Storage DiseaseWolman DiseaseAcid Cholesteryl Ester Hydrolase Deficiency, Type 2Acid Lipase DeficiencyLIPA DeficiencyLAL-DeficiencyNCT01633489Alexion Pharmaceuticals, Inc.300
已完成
不适用
Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry StudyBreast CancerNCT02393924Hoffmann-La Roche311