Real-World Outcomes of Ofatumumab: Relapse Rates, Disease Progression, and Treatment Patterns in Germany and Japan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Proportion of Patients Persistent With OMB
研究概览
简要总结
This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria:
- •Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS).
- •Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT).
- •Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period.
- •Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death).
排除标准
- •Patients will be excluded if they meet any of the following criteria:
- •Have inactive SPMS or primary progressive multiple sclerosis (PPMS).
- •Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
OMB Cohort
Adult patients diagnosed with RMS and newly treated with OMB.
OMB Treatment Naïve (OMBn) Cohort
A sub-group of the OMB Cohort. Patients with no record of treatment with a DMT before starting OMB treatment.
OMB Treatment Switch (OMBs) Cohort
A sub-group of the OMB Cohort. Patients who used at least one DMT before starting OMB treatment.
DMT Cohort
Adult patients diagnosed with RMS who began new treatment with a DMT and had no record of treatment with OMB.
Low Efficacy Treatment (LET) Cohort
A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an LET.
LET Treatment Naïve (LETn) Cohort
A sub-group of the LET Cohort. Patients with no record of a DMT before staring an LET.
LET Treatment Switch (LETs) Cohort
A sub-group of the LET Cohort. Patients who used at least one DMT before starting an LET.
Medium Efficacy Treatment (MET) Cohort
A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an MET.
MET Treatment Naïve (METn) Cohort
A sub-group of the MET Cohort. Patients with no record of a DMT before staring an MET.
MET Treatment Switch (METs) Cohort
A sub-group of the MET Cohort. Patients who used at least one DMT before starting an MET.
High Efficacy Treatment (HET) Cohort
A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is a HET.
HET Treatment Naïve (HETn) Cohort
A sub-group of the HET Cohort. Patients with no record of a DMT before starting a HET.
HET Treatment Switch (HETs) Cohort
A sub-group of the HET Cohort. Patients who used at least one DMT before starting a HET.
结局指标
主要结局
Proportion of Patients Persistent With OMB
时间窗: 6 months, 12 months
Persistence is defined as the absence of evidence of treatment switch or discontinuation at pre-defined timepoints of interest (6 months, 12 months follow-up).
Proportion of Patients Adherent to OMB
时间窗: 6 months, 12 months
Adherence measured using the proportion of days covered (PDC). PDC is defined as the number of days covered by the treatment divided by the period considered in the analysis, including overlaps between prescriptions.
次要结局
- Number of Patients per Top 10 Comorbidities Observed During the Baseline Period(Baseline)
- Frequency of at least One All-cause and MS-specific Hospitalization During the Baseline Period(Baseline)
- Number of Patients by Type of Treatment(Baseline, up to approximately 4 years)
- Duration of Treatment(Baseline, up to approximately 4 years)
- Number of Treatments Used(Baseline, up to approximately 4 years)
- Number of Patients by Sequence of Treatments Used(Baseline, up to approximately 4 years)
- Number of Patients by Line of Therapy (LOT)(Baseline, up to approximately 4 years)
- Percentage of Patients Who Switch Treatment(Up to approximately 4 years)
- Percentage of Patients Who Discontinue OMB Treatment(Up to approximately 4 years)
- Number of Patients by Treatments Received After OMB Treatment(Up to approximately 4 years)
- Baseline Demographics(Baseline)
- Number of Patients by Index Year(Baseline)
- Charlson Comorbidity Index (CCI) Score(Baseline)
- Number of Hospitalizations Per Person Year(Baseline)
- Number of Relapses Per Person Year(Baseline)