Home Based Infusions for Ocrelizumab

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Ocrelizumab at home

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04650321

20-2153

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Home infusion of ocrelizumab

Experimental group

Description:

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

Treatment:

Drug: Ocrelizumab at home