Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies (PREMIERE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 1,161
- 试验地点
- 1
- 主要终点
- Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia
研究概览
简要总结
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior enrollment into selected oral cladribine clinical trials as of randomization to either study drug or placebo, once participation in the clinical trial has ended
- •Written informed consent was given
排除标准
- •Participants who cannot be reached by telephone
- •Participants unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires
- •Participants who - either during the lag interval or subsequently enter an interventional study
结局指标
主要结局
Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia
时间窗: up to 3251 days
Persistent lymphopenia was defined as Grade 3 (less than \[\<\] 500-200 per millimeter \[mm\] \^3 or \< 0.5-0.2 multiply \[\*\]10\^9 per Liter) or Grade 4 (\< 200/mm\^3 or \< 0.2\*10\^9 per Liter) lymphopenia as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The resolution is the achievement of a CTCAE Grade 1 (\< lower limit of normal \[LLN\] to 800 per mm\^3 or \< LLN to 0.8\*10\^9 per Liter) or Grade 0 (\< 910 per mm\^3 ) lymphocyte count. Persistent Lymphopenia was reported only in Cladribine group, hence results are reported only for "Exposed to Cladribine" arm. Time to resolution is reported.
Number of Participants With Adverse Events (AEs) in the "Blood and Lymphatic System Disorders" System Organ Class (SOC) and in the "Neoplasms Benign, Malignant, and Unspecified" SOC
时间窗: up to 3251 days
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug.
Number of Participants With Serious Adverse Drug Reactions (SADRs)
时间窗: up to 3251 days
SADR is an adverse drug reaction that fulfils at least one of the seriousness criterion; results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is otherwise considered as medically important. An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the restoration, correction, or modification or physiological functions. Number of participants with SADRs were reported.
次要结局
- Number of Participants With Pregnancy Outcomes(up to 3251 days)