A Phase IV Multi-Centric Post-Marketing Study Evaluating the Safety, Immunogenicity and EFFICACY of the Marketed Formulation of Hetero - Rituximab
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Incidence, severity, outcome, duration, action taken, and causality of individual adverse events [Expected and Unexpected adverse events (Serious and Non-serious Adverse Events)] reported during the study
研究概览
简要总结
This is an open-labeled, prospective, non-comparative, interventional postmarketing study in patients indicated and treated with marketing formulation of Hetero-Rituximab. The present study will gather the data of at least 200 patients. The primary objective is to evaluate the safety and tolerability of Rituximab under post marketing phase. The secondary objectives are to evaluate the immunogenicity and efficacy of Rituximab under post marketing phase. All patients will be monitored for significant clinical signs and symptoms and laboratory abnormalities during treatment. Immunogenicity will be evaluated by assessing serum for the presence of anti-rituximab antibodies in at least 100 indicated patients at screening, at the end of 6-8 cycles or the end of study, if happens earlier. Long term immunogenicity will be evaluated at the end of 12 months from baseline. At least 100 patients who undergo immunogenicity will also undergo efficacy assessments in according to the disease for which its indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
- •Male and female adult patients, 18 years or older.
- •Patients with the following indications o Patients with diagnosed Non-Hodgkin’s lymphoma o Patients with diagnosed Chronic Lymphocytic Leukemia (CLL) o Patients with diagnosed Rheumatoid arthritis
- •Any other patients indicated Rituximab as per physician’s discretion according to the prescribing information.
- •Adequate liver, renal, cardiac and haematological function as evidenced by: o Transaminase (alanine transaminase [ALT]/aspartate transaminase [AST]) less than 2x upper limit of normal, or less than 5x upper limit of normal for patients with liver involvement o Bilirubin <1.5 times ULN or total bilirubin ≤1.5 mg/dl, or total bilirubin ≤3 mg/dl for patients with Gilbert’s syndrome o Absolute Neutrophil count ≥1500/mm o Platelet count ≥100,000/mm o Serum Creatinine less than 1.5x upper limit of normal o Left ventricular ejection fraction (LVEF) ≥50%.
排除标准
- •Patients with clinical history/ evidence of allergy/hypersensitivity to murine proteins or components of Hetero-Rituximab.
- •An active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
- •Major surgery within 4 weeks of study start
- •Need for emergency therapy such as neurologic compression syndrome
- •Receipt of live vaccine within 4 weeks prior to study drug administration
- •Current medical history/clinical evidence of hepatitis B or hepatitis C infection or HIV
- •Patients who are likely to be pregnant or lactating patients
- •Patients with history or pre-existing clinical evidence of medically significant abnormality or requirements for surgery that precludes the usage of Hetero-Rituximab, as per investigator’s discretion.
结局指标
主要结局
Incidence, severity, outcome, duration, action taken, and causality of individual adverse events [Expected and Unexpected adverse events (Serious and Non-serious Adverse Events)] reported during the study
时间窗: All visits
次要结局
- Immunogenicity - development and change in antidrug antibodies (ADA) titer against Hetero – Rituximab(Screening, 6-8 cycles and 12 months)
- Efficacy- Change in efficacy(at end of 6-8 cycles)