Home Based Infusions for Ocrelizumab
Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Ocrelizumab at home
What it measured
Main measures
Severe infusion reactions
24 hours after infusion
Infusion reactions
24 hours after infusion
Other measures (8)
Severe infusion reactions compared to historic controls.
24 hours after infusion
Infusion reactions compared to historic controls.
24 hours after infusion
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical
2 months
Quality of life (reported by participants)Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental
2 months
Quality of life (reported by participants)Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety
2 months
Mood and sleepQuality of life (reported by participants)Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression
2 months
Mood and sleepQuality of life (reported by participants)Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)
2 months
Quality of life (reported by participants)Adverse events
2 months
Safety
Who could take part
Relapsing and progressive · 18 to 55
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
Papers
Results
Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis.Ann Clin Transl Neurol · 2023
Results
Vollmer TL, Cohen JA, Alvarez E, Nair KV, Boster A, Katz J, Pardo G, Pei J, Raut P, Merchant S, MacLean E, Pradhan A, Moss B. Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Mult Scler Relat Disord. 2020 Nov;46:102454. doi: 10.1016/j.msard.2020.102454. Epub 2020 Aug 18.
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History
- Status changed from Recruiting to Status unknown
Started
Mar 2021
Main results due
Aug 2021
Finished
Aug 2021