Home Based Infusions for Ocrelizumab

Launched by UNIVERSITY OF COLORADO, DENVER · Dec 1, 2020

Keywords

ClinConnect Summary

The "Home Based Infusions for Ocrelizumab" clinical trial is looking at the safety and effectiveness of receiving ocrelizumab infusions at home for patients with Multiple Sclerosis (MS). Ocrelizumab is a medication used to help manage certain types of MS, and this study aims to see if it is safe and works well when given in a comfortable home setting instead of a hospital or clinic. The trial is currently recruiting participants who are between 18 and 55 years old, have been diagnosed with primary progressive or relapsing MS, and live in the Denver metro, Fort Collins, or Colorado Springs area.

To be eligible, participants must have already received their first dose of ocrelizumab and have a specific measure of their disease severity that falls within a certain range. They should also be able to understand and complete questionnaires in English. If you join the study, you can expect to receive your treatment at home, which may make it more convenient for you. It's important to note that certain health conditions or being pregnant will exclude individuals from participating. Overall, this trial offers a unique opportunity to receive MS treatment in a more personalized environment while helping to advance our understanding of home-based care.

Gender

ALL

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.