Characterizing the Use of Ofatumumab in a Real World Setting

Study Overview
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Brief Summary
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This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.

Detailed Description
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This study will be run in two parts. Part I will operate as a Secondary Use of Data study and Part II will operate as a Non-Interventional primary use of data study. Part I: This study is descriptive in nature without any key underlying hypothesis and will explore the onboarding and adherence of RMS patients in Australia to ofatumumab treatment. De-identified patient-level onboarding and adherence data will be primarily generated and managed through the MSGo platform which will function as a Patient Support Service. Part II: This part of the study will operate as a non-interventional primary use of data study and will explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. This part of the study will only be conducted at a selection of participating clinics. Patients in this part of the study will also have data collected as part of Part I of the study. The data for the PROs will be collected through a mobile based application .

Official Title
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Secondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS)

Conditions
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Relapsing Multiple Sclerosis

Intervention / Treatment
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* Other: ofatumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse Expanded Disability Status Scale (EDSS) of 5.5 or lower (aligned with the plannedKEP criteria). Patients accessing ofatumumab through the PBS would have to meet the finalised restriction criteria (to be confirmed). Patients will provide consent to participate in Part I of the study through the MSGo experience program or patient support program onboarding process. Patients will need to provide additional consent to participate in Part II sub-study. Exclusion Criteria: Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information].

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Part I study cohort<br>Retrospective data analysis of up to 1500 de-identified participants contributing onboarding and adherence data via the MSGo Kesimpta Patient App. | Other: ofatumumab<br>* There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|
| Part II study cohort<br>Up to 100 participants responding to PROs via the MSGo Patient App | Other: ofatumumab<br>* There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part I and II: Proportion of doses not completed within three days of the expected date | Proportion of doses not completed within three days of the expected date during initiation to be collected | Initiation | 
| Part I and II: Proportion of doses not completed within 3 days of the expected date | Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected | First 3 months of maintenance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part I: Proportion of doses not completed within three days of the expected date | Proportion of doses not completed within three days of the expected date to be collected | initiation period plus 12 months of maintenance | 
| Part I: Proportion of doses not completed within 14 days of the expected date | Proportion of doses not completed within 14 days of the expected date to be collected | 12 months of maintentance | 
| Part I: Proportion of participants with a treatment interruption of more than six months during maintenance | Proportion of participants with a treatment interruption of more than six months during maintenance to be collected. Interruption is calculated as 6 doses not completed | Up to 18 months | 
| Part I: Proportion of participants discontinued within three months of the intial dose | Proportion of participants discontinued within three months of the intial dose to be collected | Up to 18 months | 
| Part I: Proportion of participants discontinued within 12 months of the intial dose. | Proportion of participants discontinued within 12 months of the initial dose to be collected | Up to 18 months | 
| Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups | Patient sub-groups will be compared to either other complementary sub-groups or the all patients cohort | 12 months | 
| Part II: Proportion of doses not completed within 14 days of the expected date | This outcome measure will be measured for those patients who have MRI completed at approximately 18 months | during 18 months of maintenance | 
| Part II: proportion of participants discontinued within 18 months of the intial dose | This outcome measure will be measured for those patients who have MRI completed at approximately 18 months | within 18 months of the initial dose | 
| Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire | The Work Productivity and Activity Impairment (WPAI) measures Four domain specific scores assessing work productivity and activity impairment (Absenteeism; Presenteeism; Mean work productivity; Activity impairment). Scores range from 0 to 100%. The four scores are expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment. | Baseline,6 months, 12 months, 18 months | 
| Part II: Change in generic health status as measured by the EQ5D | It comprises of a short descriptive system questionnaire and a visual analogue scale (VAS). The questionnaire provides a simple descriptive profile of a respondents health state and the VAS provides an alternative way to elicit an individuals rating of their own overall current health. Scale is rated from 0 (worst imaginable health) to 100 (the best imaginable scale) | Baseline, 6 months, 12 months, 18 months | 
| Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC). | The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). | Baseline, 6 months, 12 months, 18 months | 
| Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4) | TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction . | Day 28, 6 months, 12 months, 18 months | 
| Part II: Proportion of self administration | Proportion of self administration as calculated by the number of self administered doses compared to the total number of doses over the total study time | 18 months | 
| Part II: Proportion of patients initiating ofatumumab who are treatment naïve | Proportion of patients initiating ofatumumab who are treatment naïve relative to prior high efficacy therapy as defined in Australia as alemtuzumab, ocrelizumab, natalizumab and cladribine) and other non-high efficacy Disease Modifying Therapies (DMTs). | Baseline | 
| Part II: Change in Expanded Disability Status Scale (EDSS) | EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. EDSS scores range between 0 and 10 in 0.5 unit increments. Scores increase when the severity of the disability increases | Baseline, 6 months, 12 months | 
| Part II: Annualized relapse rate | Measured by number of relapses over a period of approximately 12 months. | 12 months | 
| Part II: Number of T1 Gd-enhancing lesions per MRI scan | This will only be assessed where gadolinium is used as per Institution's usual practice. Otherwise, this will not be reported | Baseline, 6 months, 12 months | 
| Part II: Number of new or enlarging T2 lesions on MRI | Number of new or enlarging T2 lesions on MRI to be collected | Baseline, 6 months, 12 months | 
| Percentage brain volume change | The percent brain volume change analysis will be performed at 12 months follow up (either Month 12 (cf. Baseline) or Month 18 (cf. Month 6), via use of the SIENA method for atrophy analysis. | 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ofatumumab, NIS, RMS