Home Based Infusions for Ocrelizumab

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

The goal is to assess the safety and effectiveness of home ocrelizumab infusion.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Ocrelizumab at home

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brooke Valdez, BS; Phone Number: 303-724-2635; Email: brooke.valdez@cuanshutz.edu

Study Locations

• United States
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Recruiting
      • Amerita
      • Contact: Kathline Perkins, RN; Phone Number: 303-355-4745; Email: kperkins@ameritaiv.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Home infusion of ocrelizumab; Patients will receive infusion of ocrelizumab at home, instead of at clinic.	Drug: Ocrelizumab at home; Patients will receive ocrelizumab infusion at home.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Timothy L Vollmer, MD, University of Colorado - Anschutz Medical Campus

Publications and helpful links

General Publications

• Vollmer TL, Cohen JA, Alvarez E, Nair KV, Boster A, Katz J, Pardo G, Pei J, Raut P, Merchant S, MacLean E, Pradhan A, Moss B. Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Mult Scler Relat Disord. 2020 Nov;46:102454. doi: 10.1016/j.msard.2020.102454. Epub 2020 Aug 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (ACTUAL): December 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Physiological Effects of Drugs; Immunologic Factors; Ocrelizumab
• Other Study ID Numbers: 20-2153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No