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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
View on ClinicalTrials.gov →
NCT04650321
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
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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
View on ClinicalTrials.gov →
NCT04650321