NCT02199288已完成不适用
A NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFECTIVENESS, SAFETY AND NURSE MANAGEMENT DURING INDUCTION TREATMENT WITH MABTHERA S.C. FOLLOWING A FIRST INITIAL MABTHERA I.V. TREATMENT, IN PATIENTS WITH NON-HODGKINS LYMPHOMA IN A REAL-LIFE SETTING
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Response rate using the International Working Group criteria
研究概览
简要总结
This prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8 months.
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
- •Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation:
- •As treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
- •As treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with chemotherapy
- •At least 4 treatment cycles with MabThera is planned
- •Patients >/= 18 years at inclusion
- •Patients written informed consent
- •Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study
排除标准
- •Contraindications according to SPC for MabThera SC formulation:
- •Hypersensitivity for the active substance or murine antibodies, hyaluronidase or any other excipients
- •Active and severe infections
- •Patients with severe immunsuppression
- •Patient included in clinical trials with experimental pharmaceuticals
结局指标
主要结局
Response rate using the International Working Group criteria
时间窗: 8 months
次要结局
- Incidence of adverse events(Through to end of study, up to approximately 1 year)
- Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV(Through to end of study, up to approximately 1 year)
- Incidence of serious adverse events(Through to end of study, up to approximately 1 year)
研究者
相似试验
已完成
不适用
A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung AdenocarcinomaLung AdenocarcinomaNCT02093000Hoffmann-La Roche201
已完成
不适用
A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in aSTS in a Real World Setting in GreeceAdvanced Soft Tissue SarcomaNCT02618122Genesis Pharma S.A.63
已完成
不适用
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha TherapyRheumatoid ArthritisNCT01592292Hoffmann-La Roche90
撤回
不适用
A Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in IndiaHeart FailureNCT02047526AstraZeneca
已完成
不适用
Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in AustriaRheumatoid ArthritisNCT01877239Pfizer111