Home Based Infusions for Ocrelizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-08-31

Brief Summary

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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home infusion of ocrelizumab

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

Group Type EXPERIMENTAL

Ocrelizumab at home

Intervention Type DRUG

Patients will receive ocrelizumab infusion at home.

Interventions

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Ocrelizumab at home

Patients will receive ocrelizumab infusion at home.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No