Home Based Infusions for Ocrelizumab

Study Overview
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Brief Summary
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The goal is to assess the safety and effectiveness of home ocrelizumab infusion.

Detailed Description
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The safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. Patient reported outcomes (PROs) will compare pre to post infusion.

Official Title
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Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Ocrelizumab at home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current active patient of Rocky Mountain MS Center at the time of final study consent. Between 18-55 years of age at the time of final study consent. Diagnosis of primary progressive or relapsing MS as defined by the 2017 McDonald criteria.19 Has at minimum completed their first 600 mg dose of ocrelizumab. Is physically residing in the Denver metro, Fort Collins or Colorado Springs area at the time of final study consent. Has a Patient Determined Disease Steps (PDDS) between 0 to 6.5 20 Can complete patient reported outcomes developed and validated as English written scales. Must be able and willing to give meaningful, informed consent via electronic signature prior to participation in the study, in accordance with local and FDA regulatory requirements. Whose treating neurologist at the RMMSC feels that continuing ocrelizumab s medically appropriate based on at the time of final study consent. Exclusion Criteria: Not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion. Has previously not participated in the SaROD trial at the RMMSC site. Any of the following abnormal laboratory results as processed by a University of Colorado Hospital laboratory site and deemed clinically inappropriate to proceed with a home infusion by the treating neurologist at RMMSC.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home infusion of ocrelizumab<br>Patients will receive infusion of ocrelizumab at home, instead of at clinic. | Drug: Ocrelizumab at home<br>* Patients will receive ocrelizumab infusion at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe infusion reactions | Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology | 24 hours after infusion | 
| Infusion reactions | Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology | 24 hours after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe infusion reactions compared to historic controls. | Difference in proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls. | 24 hours after infusion | 
| Infusion reactions compared to historic controls. | Difference in proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls. | 24 hours after infusion | 
| Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical | Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being. | 2 months | 
| Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental | Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being. | 2 months | 
| Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety | Change in Neuro-QOL Anxiety values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.4 to 76.8. Higher scores mean more anxiety, and hence worse. | 2 months | 
| Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression | Change in Neuro-QOL Depression values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.9 to 75.0. Higher scores mean more depression, and hence worse. | 2 months | 
| Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS) | Change in PDDS values between pre and post infusion. | 2 months | 
| Adverse events | Number of adverse events | 2 months |