Home Based Infusions for Ocrelizumab

Description

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

Conditions

Multiple Sclerosis

Study Overview

Study Details

Study overview

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

Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions

Home Based Infusions for Ocrelizumab

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Centennial

Amerita, Centennial, Colorado, United States, 80112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Timothy L Vollmer, MD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

2021-08-31