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Home Based Infusions for Ocrelizumab

RECRUITINGPhase 4Sponsored by University of Colorado, Denver
Actively Recruiting
PhasePhase 4
SponsorUniversity of Colorado, Denver
Started2021-03-01
Est. completion2021-08-31
Eligibility
Age18 Years – 55 Years
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 18 Years – 55 YearsHealthy volunteers accepted
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.

Conditions1

Multiple Sclerosis

Locations1 site

Amerita
Centennial, Colorado, 80112
Kathline Perkins, RN303-355-4745kperkins@ameritaiv.com

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