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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCR SC | Experimental | Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCR SC | Drug | Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI). |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Neurology Associates | Birmingham | Alabama | 35209 | United States | ||
| Clinical Endpoints |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| 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) | 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. | At Day 1 (Baseline) |
| 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) | 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. | At Day 1 (Baseline) and Week 24 |
| Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II | 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. | At Weeks 24 and 48 |
| Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 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. | Baseline, Weeks 24 and 48 |
| Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching | At Baseline |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Advanced Neurology of Colorado | Fort Collins | Colorado | 80528 | United States |
| Neurology Associates - Maitland | Orlando | Florida | 32751 | United States |
| Multiple Sclerosis Center of Atlanta/Atlanta Neuroscience Institute | Atlanta | Georgia | 30327 | United States |
| Minneapolis Clinic of Neurology | Minneapolis | Minnesota | 55422 | United States |
| Ohio State University, Multiple Sclerosis and Neuroimmunology Center | Columbus | Ohio | 43210 | United States |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | United States |
| DHR Health MS Center | McAllen | Texas | 78501 | United States |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| Caribbean Center for Clinical Research | Guaynabo | 00968 | Puerto Rico |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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