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.

Condition

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 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

- 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

Study Design

Phase
Phase 3
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned 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 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.

More Details

NCT ID
NCT03085810
Status
Active, not recruiting
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.