Multiple Sclerosis
Conditions
Keywords
Primary Progressive Multiple Sclerosis, Relapsing Multiple Sclerosis
Brief summary
The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \[IV\], ocrelizumab IV) or PPMS (ocrelizumab IV).
Interventions
DRUGOCR SC
Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria * Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening) * Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study * Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy
Exclusion criteria
* Participants who have demonstrated suboptimal response to aCD20 therapy * Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy * Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure * Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus \[HIV\], syphilis, human papillomavirus \[HPV\], tuberculosis \[TB\]) * History of confirmed or suspected progressive multifocal leukoencephalopathy (PML) * Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS * Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study * Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation * Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation * Treatment with any live-attenuated vaccine within 6 weeks prior to baseline * Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency) * Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone * Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) at Week 24 | Baseline, Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24 | At Week 24 | — |
| Number of Participants With Adverse Events (AEs) | Up to Week 48 | — |
| Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gd+ Lesions as Detected by Brain MRI at Week 48 | Baseline, Week 48 | — |
| Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48 | At Week 48 | — |
| Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts at Week 24 and Week 48 | Baseline, Weeks 24 and 48 | — |
| Treatment Satisfaction Score With Prior aCD20 Therapy, as Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-II) | At Day 1 (Baseline) | TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) responses with higher scores corresponding to higher satisfaction in that domain. |
| Treatment Administration Satisfaction Score After Dose of OCR SC at Day 1 and Week 24, as Assessed Using Treatment Administration Satisfaction Questionnaire - Subcutaneous Injection (TASQ SC) | At Day 1 (Baseline) and Week 24 | TASQ SC is a 13-item questionnaire to evaluate participants' experience on their most recent OCR SC administration. The questionnaire consists of items related to SC injections, each rated on a 3- or 5-point Likert scale with higher scores corresponding to higher satisfaction and/or a more positive experience. |
| Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II | At Weeks 24 and 48 | TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) with higher scores corresponding to higher satisfaction in that domain. |
| Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 48 | Baseline, Weeks 24 and 48 | MSIS-29 is a 29-item questionnaire to examine the impact of MS on physical and psychological functioning from a participant's perspective. Participants are asked to rate how much their functioning and well-being have been impacted over the past 14 days on a 4-point scale, from 1 = "Not at all" to 4 = "Extremely". The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS. |
| Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching | At Baseline | — |
Countries
Puerto Rico, United States
Contacts
CONTACTReference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed