A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Efficacy and Safety of Ofatumumab 20 mg Subcutaneous (s.c.) Injection in Relapsing Multiple Sclerosis (RMS) Patients in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 19
- 主要终点
- Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of ofatumumab s.c. in adult participants with relapsing multiple sclerosis (RMS) in China.
详细描述
This study consisted of three periods, Screening (up to 30 days), Treatment (12 months) and Post-treatment follow-up (6 months). It was an open-label single-arm study so all participants received the study drug. The first dose was administered in the clinic and the remaining doses were administered at home. The doses were administered at Baseline/Week 0, Week 1, Week 2, and followed by subsequent monthly dosing starting at Week 4.
Participants were required to come into the clinic for one screening visit, and 5 visits during the Treatment period for clinical evaluation and lab tests. Participants who completed the 12-month treatment had Post treatment Follow-Up visits at End of Study plus 3 months (EOS + 3M) and EOS + 6M, unless the participants decided to continue with commercially available ofatumumab treatment outside of the study.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Chinese aged 18-55 years (inclusive) at their enrollment of the study (signing the study consent form).
- •Clinical definite diagnosis of RMS according to the 2017 Revised McDonald criteria (Thompson et al 2018, and the documentation prior to their enrollment to the study (signing the study consent form) of:
- •Two documented relapses during the past 2 years, or
- •One documented relapse during the last year, or
- •A positive Gd-enhancing MRI scan during the year prior to Screening. Note: Screening MRI scan may be used if no positive Gd-enhancing scan exists from prior year.
- •Disability status with an EDSS score of 0 - 5.5 (inclusive) at Screening.
- •Neurologically stable within 1 month prior to both Screening and Baseline (including no MS relapse in this period).
排除标准
- •Participants with primary progressive MS (PPMS) or secondary progressive MS (SPMS) without disease activity
- •Participants meeting criteria for neuromyelitis optica spectrum disorder (NMOSD)
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential unless using effective methods of contraception while taking study treatment and for at least 6 months after stopping medication
- •Participants with an active chronic disease of the immune system other than MS
- •Participants with neurological findings consistent with PML or confirmed PML
- •Participants with active hepatitis B disease
- •Participants with active systemic infections (including but not limited to active COVID-19 infection) or known to have AIDS or to test positive for HIV antibody at Screening
- •Participants at high risk of developing or having reactivation of syphilis or tuberculosis
- •Have received any live or live-attenuated vaccines within four weeks prior to first study drug administration
- •Have been treated with medications as specified or within timeframes specified in the protocol
- •Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the participants to cooperate and comply with the study procedures.
研究组 & 干预措施
Ofatumumab
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
干预措施: Ofatumumab (Biological)
结局指标
主要结局
Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses
时间窗: Baseline up to approximately 12 months
A confirmed MS relapse is defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Adjusted ARR was obtained from fitting a negative binomial regression model adjusted for number of relapses in the previous year, baseline number of T1 Gd-enhancing lesions and baseline age as continuous covariates (offset: Natural log of time in study in years).
次要结局
- Number of Adverse Events and Serious Adverse Events(Baseline to safety cut-off up to approximately 15.2 months)
- Number of Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan(Baseline up to approximately 12 months)
- Annualized Rate of New or Enlarging T2 Lesions(Baseline up to approximately 12 months)
- Change in T2 Lesion Volume Relative to Baseline(Baseline up to approximately 12 months)
- Percentage Change in T2 Lesion Volume Relative to Baseline(Baseline up to approximately 12 months)