search
Back to results

Home Based Infusions for Ocrelizumab

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ocrelizumab at home
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AmeritaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home infusion of ocrelizumab

Arm Description

Patients will receive infusion of ocrelizumab at home, instead of at clinic.

Outcomes

Primary Outcome Measures

Severe infusion reactions
Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology
Infusion reactions
Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)
Change in PDDS values between pre and post infusion.
Adverse events
Number of adverse events

Full Information

First Posted
November 16, 2020
Last Updated
June 8, 2021
Sponsor
University of Colorado, Denver
Collaborators
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04650321
Brief Title
Home Based Infusions for Ocrelizumab
Official Title
Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Single arm clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home infusion of ocrelizumab
Arm Type
Experimental
Arm Description
Patients will receive infusion of ocrelizumab at home, instead of at clinic.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab at home
Intervention Description
Patients will receive ocrelizumab infusion at home.
Primary Outcome Measure Information:
Title
Severe infusion reactions
Description
Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology
Time Frame
24 hours after infusion
Title
Infusion reactions
Description
Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology
Time Frame
24 hours after infusion
Secondary Outcome Measure Information:
Title
Severe infusion reactions compared to historic controls.
Description
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.
Time Frame
24 hours after infusion
Title
Infusion reactions compared to historic controls.
Description
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.
Time Frame
24 hours after infusion
Title
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical
Description
Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Time Frame
2 months
Title
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental
Description
Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Time Frame
2 months
Title
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety
Description
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.
Time Frame
2 months
Title
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression
Description
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.
Time Frame
2 months
Title
Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)
Description
Change in PDDS values between pre and post infusion.
Time Frame
2 months
Title
Adverse events
Description
Number of adverse events
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Valdez, BS
Phone
303-724-2635
Email
brooke.valdez@cuanshutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy L Vollmer, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amerita
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathline Perkins, RN
Phone
303-355-4745
Email
kperkins@ameritaiv.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33045496
Citation
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.
Results Reference
result

Learn more about this trial

Home Based Infusions for Ocrelizumab

We'll reach out to this number within 24 hrs