An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,882
- 试验地点
- 377
- 主要终点
- Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
研究概览
简要总结
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.
Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).
COVID-19 sub-study:
The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
- •Written informed consent
排除标准
- •Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
- •Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
- •Subjects taking medications prohibited by the protocol
- •Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
- •Vaccination sub-study:
- •Inclusion criteria
- •Informed consent
- •Actively enrolled in the COMB157G2399 Study
- •12 weeks of continuous treatment within the COMB157G2399 Study
- •prior vaccination history as per protocol-defined
- •Exclusion criteria
- •known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
- •allergies to egg or shellfish
- •any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
- •any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ofatumumab
Subcutaneous injection
干预措施: Tetanus toxoid (TT) containing vaccine (Td, Tdap) (Biological)
Ofatumumab
Subcutaneous injection
干预措施: 23-valent pneumococcal polysaccharide vaccine (23-PPV) (Biological)
Ofatumumab
Subcutaneous injection
干预措施: 13-valent pneumococcal conjugate vaccine (13-PCV) (Biological)
Ofatumumab
Subcutaneous injection
干预措施: Seasonal Quadrivalent influenza vaccine (Biological)
Ofatumumab
Subcutaneous injection
干预措施: Ofatumumab (Biological)
Ofatumumab
Subcutaneous injection
干预措施: Keyhole limpet hemocyanin (KLH) neo-antigen (Biological)
结局指标
主要结局
Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
时间窗: Up to 8 years
次要结局
- Number of relapse rates per year(Data from the core studies through the first 5 years in this study.)
- Patients with confirmed 3 and 6 month disability worsening(During the first 5 years of treatment in the study.)
- Patients with confirmed 6, 12, and 24 month disability improvement and improvement during the first 5 years of the study.(During the first 5 years of treatment in the study.)
- Patients with changes in Expanded Disability Status Scale (EDSS) scores(Data from the core studies through the first 5 years in this study, (depending on if first dose was in the core or in this extension study or comparator randomization))
- Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores(During the first 5 years of the study.)
- Changes in the Magnetic Resonance Image (MRI) related to brain volume loss(Data from the core studies through the first 5 years in this study.)
- Changes in the Magnetic Resonance Image (MRI) related to T2 lesions(Data from the core studies through the first 5 years in this study.)
- Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions(Data from the core studies through the first 5 years in this study.)
- Changes in neurofilament light change serum concentration(Data from the core studies through the first 5 years in this study.)