Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

Study Overview
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Brief Summary
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This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia.

Detailed Description
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Patients with RMS receiving Ocrelizumab or Ofatumumab will be recruited to measure the time spend for Healthcare Providers (HCP) (neurologist, nurse and hospital pharmacist) on preparing, administering the medication and following up with the patient.

Official Title
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Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

Conditions
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Relapsing Forms of Multiple Sclerosis

Intervention / Treatment
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* Drug: Ocrelizumab
* Drug: Ofatumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of 18 or more years of age. Patients with confirmed diagnosis of RMS (CIS, RRMS or aSPMS) following 2017 McDonnald criteria. Patients currently prescribed with Ocrelizumab or Ofatumumab to treat MS according to the Summary of Product Characteristics (SmPC). The decision must be based on patient disease and taken before the decision of inviting the patient to participate in this study. Patients literate in English. Patients must provide informed consent to participate in the study. Exclusion Criteria: Patients currently participating in any other RMS clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Ocrelizumab<br>Ocrelizumab is administered intravenously (IV) under the guidance of a specialized physician and followed by one-hour observation after the infusion. It requires a corticosteroid pre-medication and some antipyretics may also be administered. | Drug: Ocrelizumab<br>* There is no treatment allocation. Patients administered Ocrelizumab by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|
| Ofatumumab<br>Ofatumumab is administered through a subcutaneous injection and allows self-administration after training. | Drug: 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 |
| --- | --- | --- |
| Time spent by Healthcare Providers (staff) in the preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab | Describe and compare the time spent by Healthcare Providers (in minutes) in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab in patients with Relapsing forms of Multiple Sclerosis at each event (initial, loading and subsequent doses). | Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare resources used, in terms of consumables in the treatment preparation and administration of Ocrelizumab and Ofatumumab | Describe and compare the healthcare resources used, in terms of number of consumables used, in the treatment preparation and administration of Ocrelizumab and Ofatumumab for RMS patients at each event. | Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12) | 
| Cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab | Describe and compare the cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab for RMS patients at each event. | Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12) | 
| Healthcare resources used, in terms of staff time in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab | Describe and compare the healthcare resources used, in terms of staff time in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab in RMS patients at each event. | Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12) | 
| Healthcare resources used, in terms of consumables in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab | Describe and compare the healthcare resources used, in terms of number of consumables used in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab in RMS patients at each event. | Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12) | 
| Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS | Describe and compare as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS) at each event. The WPAI measures four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Overall productivity loss (overall impairment / absenteeism plus presenteeism); 4. Usual activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity | Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12) | 
| Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG) | Describe and compare as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG), at each event. The WPAI measures four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Overall productivity loss (overall impairment / absenteeism plus presenteeism); 4. Usual activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity | Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing forms of Multiple Sclerosis, RMS, Ocrelizumab, Ofatumumab, TIMIOS