Multiple Sclerosis study: OCR SC
Official title A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
ClinicalTrials.gov ID: NCT07609719
What this study is testing
What is OCR SC?
an investigational subcutaneous formulation of ocrelizumab being studied as a potential treatment for multiple sclerosis is designed to target CD20-positive B cells
Also referred to as Ocrevus, RO4964913.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a new under-the-skin injection is safe and works well for people with multiple sclerosis who are changing from a different similar treatment.
- Who it's for
- People with relapsing or primary progressive multiple sclerosis who are currently taking or switching from another approved drug that targets CD20.
- What's involved
- Participants will receive the new under-the-skin injection and undergo regular health checks, including brain scans and blood tests, to monitor their condition and any side effects.
- Time commitment
- The study involves regular visits for treatment and testing over a period of time, though the exact duration is not specified in the provided text.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy
You likely can't join if
- 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...
- 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]...
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
See the full eligibility 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...
- Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy
- 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)
- 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 exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Fort Collins, Colorado, United States
- Maitland, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Cordova, Tennessee, United States
- Guaynabo, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Fort Collins, Colorado, United States; Maitland, Florida, United States; Atlanta, Georgia, United States; Savannah, Georgia, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.