Multiple Sclerosis
Conditions
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.
Interventions
DRUGOcrelizumab at home
Patients will receive ocrelizumab infusion at home.
Sponsors
Genentech, Inc.
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe infusion reactions | 24 hours after infusion | Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology |
| Infusion reactions | 24 hours after infusion | Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical | 2 months | Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being. |
| Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental | 2 months | Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being. |
| Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety | 2 months | Change in Neuro-QOL Anxiety values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.4 to 76.8. Higher scores mean more anxiety, and hence worse. |
| Severe infusion reactions compared to historic controls. | 24 hours after infusion | Difference in proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls. |
| Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS) | 2 months | Change in PDDS values between pre and post infusion. |
| Adverse events | 2 months | Number of adverse events |
| Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression | 2 months | Change in Neuro-QOL Depression values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.9 to 75.0. Higher scores mean more depression, and hence worse. |
| Infusion reactions compared to historic controls. | 24 hours after infusion | Difference in proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls. |
Countries
United States
Contacts
Primary ContactBrooke Valdez, BS
Outcome results
None listed