Vanderbilt Clinical Trials

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Purpose

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

Condition

Multiple Sclerosis, Relapsing-Remitting

Eligibility

Eligible Ages: Between 18 Years and 55 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria - Have a length of disease duration, from first documented clinical attack consistent with MS disease of less than or equal to (</=) 3 years - Within the last 12 months one or more clinically reported relapse(s) or one or more signs of MRI activity - EDSS of 0.0 to 3.5 inclusive, at screening - An agreement to use an acceptable birth control method for women of childbearing potential, during the treatment period and for at least 6 months or longer after the last dose of study drug

Exclusion Criteria

Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS - Inability to complete an MRI - Known presence of other neurological disorders Exclusions Related to General Health: - Pregnancy or lactation - Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study - History or currently active primary or secondary immunodeficiency - Lack of peripheral venous access - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study - Congestive heart failure (New York Heart Association III or IV functional severity) - Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening - History of malignancy, major opportunistic infections, alcohol or drug abuse, recurrent or chronic infection, and/or coagulation disorders Exclusions Related to Medications: - Received any prior approved disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate - Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit - Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) - Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone marrow transplantation) - Treatment with investigational DMT - Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to screening Exclusion related to Shorter Infusion Substudy: - Any previous serious IRRs experienced with ocrelizumab treatment

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Ocrelizumab	Ocrelizumab will be administered intravenously (IV) as two 300-milligram (mg) infusions (infusion length=2.5 hours) on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period.	Drug: Ocrelizumab Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Active Comparator Substudy Group 1	At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 3.5 hours every 24 weeks for the remainder of the study duration	Drug: Ocrelizumab Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Experimental Substudy Group 2	At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 2 hours followed by sodium chloride given as a slow infusion over the remaining 1.5 hours to mimic the standard-length infusion (3.5 hour) every 24 weeks for the remainder of the study duration	Drug: Ocrelizumab Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

More Details

Status: Completed
Sponsor: Hoffmann-La Roche

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.