Retrospective Observational Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab: a Subanalysis of the RTXM83-AC-01-11 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Security evaluation: sub-analysis of the adverse events
研究概览
简要总结
The RTXM83-AC-01-11 study evaluated efficacy and safety outcomes in relation to the use of Vivaxxia during 6 treatment cycles (at the investigator's discretion, up to 8 treatment cycles could be administered), followed by 9 months of follow-up. , this follow-up time being sufficient for the analysis of non-inferiority in relation to the reference medicine. However, data on late events of efficacy and safety are of great value to contribute to a robust clinical response and to strengthen confidence in the use of biosimilar medicines. For this reason, Libbs Farmacêutica proposes this retrospective observational study to collect data on late outcomes of the pivotal study that directed the approval of the biosimilar rituximab (Vivaxxia) from the research participants from Brazil.
The present retrospective observational study LB2002 will sub-analyze selected results of efficacy and safety from study RTXM83-AC-01-11 in participants over 18 years of age randomized in Brazil, totaling 28 participants, in addition to evaluating late efficacy and safety outcomes. Information on subsequent treatment / protocol should also be collected for participants who have progressive or recurrent disease, instituted by research centers under these conditions.
The proposal is to compare descriptively the selected outcomes of efficacy and safety of these participants with the same outcomes selected for the global population in the RTXM83-AC-01-11 study, and also provide late safety and effective data important for anti-neoplastic processes.
详细描述
Evaluate research participants who were refractory to treatment, defined as not having achieved: Complete Response (CR) or Partial Response (PR), after 6 treatment cycles in study RTXM83-AC-01-11.
Evaluate the participants who had a recurrence of the disease, defined as a change from: Complete Response (CR), after 06 treatment cycles in study RTXM83-AC-01-11, to: Progressive Disease (PD) until the date of consent (ICF) in the LB2002 study.
The data of the subsequent treatment / protocol instituted by the research center for progressive or recurrent disease will also be collected.
PERIOD OF ANALYSIS OF THIS CLINICAL STUDY
- 01-JUL-2013 (beginning of the study) to 17-JUL-2017 (data in which the last participant of the study RTXM83-AC-01-11 arrived at the last follow-up visit at 9 months after the last dose of treatment): for sub-analysis of efficacy and safety proposed by study RTXM83-AC-01-11: SLE, TRG and EA, and for exploratory evaluation of refractory disease.
- Data from randomization in study RTXM83-AC-01-11 to consent data (TCLE) in study LB2002: for analysis of SLP, SG and for exploratory evaluation of relapse.
- Date of the final visit of study RTXM83-AC-01-11, considered as FUP3, until the date of consent (ICF) in study LB2002: for the evaluation of late AEs of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Free and informed consent to participate in this retrospective, observational study of data collection
- •Research participants from Brazil randomized and who received at least one dose of treatment in the RTXM83-AC-01-11 study.
排除标准
- •not applicable
结局指标
主要结局
Security evaluation: sub-analysis of the adverse events
时间窗: 9 months after treatment
Present the sub-analysis of the adverse events (AE) of the participants in Brazil that occurred from the date of signing the Free and Informed Consent Form (ICF) until the final visit of the study RTXM83-AC-01-11, considered as the FUP 3 (follow-up) 9 months after the end of treatment);
Effectiveness evaluation: Assess the overall survival
时间窗: From date of randomization until the date of death from any cause, assessed up to 96 months
Assess the overall survival in the two treatment groups (RTXM83-CHOP and R-CHOP) from the date of randomization in study RTXM83-AC-01-11 until the date of consent (ICF) in study LB2002;
Effectiveness evaluation: subanalysis of event-free survival
时间窗: 9 months after treatment
To present the subanalysis of event-free survival of participants from Brazil in the two treatment groups (RTXM83-CHOP and R-CHOP) from the randomization date until the final visit of the RTXM83-AC-01-11 study, considered as o FUP 3 (9-month follow-up after the end of treatment);
Effectiveness evaluation: subanalysis of the Global Response Rate
时间窗: At the end of Cycle 6 (each cycle is 03 weeks)
To present the subanalysis of the Global Response Rate of participants from Brazil in the two treatment groups (RTXM83-CHOP and R-CHOP), after 6 treatment cycles in the RTXM83-AC-01-11 study, assessed as Complete Response ( RC) or Partial Response (PR);
Security evaluation: occurrence of late adverse events
时间窗: From date of randomization until the date of death from any cause, assessed up to 96 months
Evaluate the occurrence of late adverse events of interest from the date of the final visit of the RTXM83-AC-01-11 study, considered as FUP 3, until the date of consent (TCLE) in the LB2002 study.
Effectiveness evaluation: progression-free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months
Assess progression-free survival in the two treatment groups (RTXM83-CHOP and R-CHOP) from the date of randomization in the RTXM83-AC-01-11 study until the date of consent (ICF) in the LB2002 study;
次要结局
未报告次要终点