NCT04847596已完成不适用
An Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving immune response - immune assay No. 1
研究概览
简要总结
This is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. Patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. Fully vaccinated participants must be able to complete immune assay No.1 ≥ 14 days after the second dose of vaccine
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study
- •Age 18-55 years old inclusive at Screening
- •Diagnosis of relapsing MS by 2017 revised McDonald criteria
- •Must be willing to comply with the study schedule
- •Have received/scheduled vaccination with a FDA approved for emergency use COVID-19 mRNA vaccine (either Pfizer or Moderna) (i) either been scheduled for vaccine, (ii) received a single vaccine with a scheduled second dose, or (iii) already completed full course (two dose) vaccination.
- •Currently receiving ofatumumab for the treatment of RMS (Preoftumumab serology with Hepatitis B testing showing no active or latent infection, as well as serum IgG results to be recorded in the database if available)
排除标准
- •Known clinical diagnosis of COVID-19 prior to screening based on investigator's or patient's personal physician's judgement
- •Has a contraindication to receiving an mRNA COVID-19 vaccine
- •Has an immediate allergic reaction to past vaccine or injection
- •Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to vaccination as determined by the HCP
- •Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
- •Prior treatment with S1P agent within 2 months of study enrollment
- •Prior treatment with natalizumab within 6 months of study enrollment
- •Contraindications to ofatumumab treatment as per the USPI will be adhered to which include active infection hepatitis B infection, progressive multifocal leukoencephalopathy and pregnancy.
- •Participation in another interventional clinical trial within 14 days before enrollment.
- •Have been treated with any of the medications as described in the full protocol
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after stopping medication
结局指标
主要结局
Proportion of participants achieving immune response - immune assay No. 1
时间窗: 14 days after full course vaccination (two doses)
Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay. (yes/no)
次要结局
- Proportion of participants achieving immune response - immune assay No. 2(90 days post assay 1)
- Adverse events/serious adverse events(120 days after full course vaccination)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 PatientsCOVID-19NCT05633420Shin Poong Pharmaceutical Co. Ltd.20
已完成
4 期
Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's DiseaseAlzheimer's DiseaseNCT00305903Novartis150
终止
不适用
NeuraGen 3D Pilot StudyDigital Nerve InjuryNCT05343143Integra LifeSciences Corporation1
已完成
2 期
Minimal Islet Transplant at Diabetes OnsetDiabetes Mellitus, Type 1NCT02505893Ospedale San Raffaele6
进行中（未招募）
4 期
Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal MetastasesCarcinoma, Non-Small-Cell LungBrain MetastasesLeptomeningeal MetastasisNCT06282874Guangdong Association of Clinical Trials41