Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 55 Years|
More Inclusion & Exclusion Criteria
- - Diagnosis of relapsing multiple sclerosis (RMS) (i.e., RRMS or aSPMS where participants still experience relapses) in accordance with the revised McDonald Criteria 2017.
- - At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening.
- - Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
- - Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive.
- - Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds.
- - Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds.
- - Documented MRI of brain with abnormalities consistent with MS at screening.
- - Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose.
- - For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
- - For female participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for her menopause or if surgically sterile.
- - History of primary progressive MS at screening.
- - Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening.
- - History of confirmed or suspected progressive multifocal leukoencephalopathy.
- - History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening.
- - Immunocompromised state.
- - Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
- - Inability to complete an MRI or contraindication to gadolinium administration.
- - Contraindications to mandatory pre-medications for IRRs.
- - Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study.
- - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
- - Significant, uncontrolled disease that may preclude participant from participating in the study.
- - History of or currently active primary or secondary, non-drug-related, immunodeficiency.
- - Pregnant or breastfeeding or intending to become pregnant.
- - Lack of peripheral venous access.
- - History of alcohol or other drug abuse within 12 months prior to screening.
- - Treatment with any investigational agent within 24 weeks prior to screening or treatment with any experimental procedure for MS.
- - Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy.
- - Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline.
- - Previous treatment with natalizumab within 4.5 months of baseline.
- - Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline.
- - Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab.
- - Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label.
- - Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation.
- - Any previous history of transplantation or anti-rejection therapy.
- - Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization.
- - Systemic corticosteroid therapy within 4 weeks prior to screening.
- - Positive screening tests for active, latent, or inadequately treated hepatitis B.
- - Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab.
- - Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Hoffmann-La Roche|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Peru, Poland, Portugal, Russian Federation, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon positive primary results after the double-blind phase, an optional higher dose extension treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still did not replete to their baseline level or the low level of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase following the safety follow-up phase. The study will end when all participants who were not treated with an alternative B-cell depleting therapy have repleted their B-cells to the baseline value or the lower limit of normal.
Arms & Interventions
Experimental: Ocrelizumab Higher Dose
Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Active Comparator: Ocrelizumab Approved Dose
Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Drug: - Ocrelizumab
The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (participants's body weight <75 kg) or 1800 mg (participant's body weight >/=75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion every 24 weeks.
Drug: - Ocrelizumab
Ocrelizumab will be administered at a dose of 600 milligram (mg) every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
Drug: - Antihistamine
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Drug: - Methylprednisolone
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.