Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 128
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination
研究概览
简要总结
Primary Objective:
Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population.
Secondary Objectives:
- Assess the effect of teriflunomide on immunoglobulin levels;
- Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide.
The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.
详细描述
The maximum duration of the study period for a participant was approximatively 49 days broken down as follows:
- Screening period of up to 21 days;
- Influenza vaccination at Day 1;
- Follow-up period of 28 days (±2 days).
MS treatment (Teriflunomide or interferon-β-1) was to be continued during the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient <60 years old with relapsing multiple sclerosis (RMS) either treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050, or treated with a stable dose of interferon-β-1 for at least 6 months.
排除标准
- •Concomitant infectious pathology at the time of vaccination;
- •MS relapse within 1 month before vaccination;
- •Systemic corticosteroids within 1 month before the vaccination;
- •Any contraindication to influenza vaccine;
- •Any vaccination within the last 6 months;
- •Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon-β-1);
- •Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri®), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development;
- •Prior or concomitant use of glatiramer acetate within 1 year before study entry;
- •Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry;
- •Pregnant or breast feeding women;
- •Woman of childbearing potential without adequate contraception.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Teriflunomide 7 mg
Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
干预措施: teriflunomide (Drug)
Teriflunomide 7 mg
Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
干预措施: Influenza vaccine (Biological)
Teriflunomide 14 mg
Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
干预措施: teriflunomide (Drug)
Teriflunomide 14 mg
Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
干预措施: Influenza vaccine (Biological)
IFN-β-1
Influenza vaccine in participants treated with a stable dose of Interferon-β-1 (IFN-β-1) for at least 6 months
干预措施: Interferon-β-1 (Drug)
IFN-β-1
Influenza vaccine in participants treated with a stable dose of Interferon-β-1 (IFN-β-1) for at least 6 months
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination
时间窗: 28 days post vaccination
For each viral strain (H1N1, H3N2, and B), the antibody titer, level of antibodies in blood sample when exposed to antigen, was calculated as the mean of two replicates. If the titer was below or above the limit of detection, the threshold value was used. The percentage of participants achieving a titer of 40 or more, as well as the 90% confidence interval (CI) using normal approximation were calculated for each strain and treatment group.
次要结局
- Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination(pre vaccination (baseline) and 28 days post vaccination)
- Immunoglobulin Levels(pre vaccination (baseline) and 28 days post vaccination)
- Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination(pre vaccination (baseline) and 28 days post vaccination)
- Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination(pre vaccination (baseline) and 28 days post vaccination)