Home Based Infusions for Ocrelizumab

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Genentech, Inc.
• Treatments: Ocrelizumab

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.