Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen (Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse events (SAEs)
研究概览
简要总结
This study was an uncontrolled, central registration system, open-label, multicenter observational study in patients using Kesimpta for the labeled indication.
详细描述
This was a primary data collection-based special drug-use surveillance to be conducted in accordance with the GPSP ordinance.
Observational period lasted 24 months from the start of treatment with Kesimpta.
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
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must provide written consent to cooperate in this study before the start of treatment with Kesimpta
- •Patients using Kesimpta for the first time for the following indication Indication: prevention of relapses and and prevention of physical disability progression in the following patients
- •Relapsing-remitting MS
- •Active SPMS
排除标准
- •Patients with a history of treatment with a drug containing the same ingredient as Kesimpta (investigational drug or post-marketing clinical study drug)
- •Patients with a history of hypersensitivity to any of the Kesimpta ingredients
结局指标
主要结局
Incidence of serious adverse events (SAEs)
时间窗: 24 months
A SAE is defined as an adverse event which: * Is fatal or life-threatening * Results in persistent or significant disability/incapacity * Constitutes a congenital anomaly/birth defect * Requires inpatient hospitalization or prolongation of existing hospitalization, unless hospitalization is for: * Routine treatment or monitoring of the indication under study, not associated with any deterioration in condition * Elective or pre-planned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of treatment with Kesimpta * Social reasons and respite care in the absence of any deterioration in the patient's general condition * Is medically significant, i.e., events that jeopardize the patient or may require medical or surgical intervention to prevent one of the outcomes listed above.
Incidence of adverse reactions
时间窗: 24 months
An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Kesimpta or whose causality is not recorded.
Incidence of adverse events (AEs)
时间窗: 24 months
An adverse event (AE) is any untoward medical occurrence experienced by a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not related to the medicinal product(s).
次要结局
- Physician's Global Assessment(month 12, month 24 (or at treatment discontinuation))
- Confirmed disability worsening on Expanded Disability Status Scale (EDSS)(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation))
- Confirmed improvement on Expanded Disability Status Scale (EDSS)(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation))
- Number of gadolinium (Gd)-enhancing lesions on Magnetic Resonance Imaging (MRI)(Baseline, month 6, month 12, month 18, month 24 (or at discontinuation))
- Annual relapse rate(Up to 24 months)
- No Evidence of Disease Activity (NEDA-3)(month 12, month 24)