Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 3: testing Ocrelizumab for Multiple Sclerosis
The study will measure the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the whether it is safe and how hard side effects are to live with of ocrelizumab. From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Ocrelizumab. The registry lists allocation as na. The study will measure the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the whether it is safe and how hard side effects are to live with of ocrelizumab.
They plan to enroll about 500 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
An Open-label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-trial Access Program
Primary outcome (registry wording): Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a)
Who it is for (from inclusion criteria)
Ages 18 Years to any
The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study
Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential
Who the registry excludes
Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant
Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant
Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications
Concurrent participation in any therapeutic clinical trial (other than the parent study)
Immunocompromised state
Known active malignancy or are being actively monitored for recurrence of malignancy
Public study contact (from the registry)
Reference Study ID Number: MN45053 https://forpatients.roche.com/
Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS).
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
This is a multi-center prospective rater-masked (blinded) randomly assigned controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). you would be randomly assigned at a 1 to 1 (1:1) ratio.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06675955?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06675955?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.