Summary

for people ages 18-55 (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis, Relapsing-Remitting Sclerosis Multiple Sclerosis Ocrelizumab

Eligibility

You can join if…

Open to people ages 18-55

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine accepting new patients
    Irvine California 92697 United States
  • Cleveland Clinic Lou Ruvo; Center for Brain Research accepting new patients
    Las Vegas Nevada 89106 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03085810
Phase
Phase 3
Study Type
Interventional
Last Updated