Clinical trial NCT04650321: Home Based Infusions for Ocrelizumab
Official title: Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2020-12-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm clinical trial.
Primary purpose: TREATMENT

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

Detailed description: The safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. Patient reported outcomes (PROs) will compare pre to post infusion.

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.

Primary outcomes:
measure: Severe infusion reactions
timeFrame: 24 hours after infusion
measure: Infusion reactions
timeFrame: 24 hours after infusion
Secondary outcomes:
measure: Severe infusion reactions compared to historic controls.
timeFrame: 24 hours after infusion
measure: Infusion reactions compared to historic controls.
timeFrame: 24 hours after infusion
measure: Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical
timeFrame: 2 months
measure: Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental
timeFrame: 2 months
measure: Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety
timeFrame: 2 months
measure: Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression
timeFrame: 2 months
measure: Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)
timeFrame: 2 months
measure: Adverse events
timeFrame: 2 months
Other outcomes:
Locations:
city: Centennial
country: United States
facility: Amerita
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Timothy L Vollmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.