Home Based Infusions for Ocrelizumab
Purpose
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single arm clinical trial.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Home infusion of ocrelizumab |
Patients will receive infusion of ocrelizumab at home, instead of at clinic. |
|
Recruiting Locations
Amerita
Centennial, Colorado 80112
Centennial, Colorado 80112
More Details
- NCT ID
- NCT04650321
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver
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.