Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

PHASE3CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

April 29, 2016

Primary Completion Date

April 11, 2023

Study Completion Date

April 11, 2023

Conditions
Relapsing Multiple SclerorsisMultiple Sclerosis, Primary Progressive
Interventions
DRUG

Ocrelizumab

Ocrelizumab will be administered as IV infusion.

PROCEDURE

Lumbar Puncture

Participants will receive LP as specified in individual arms. Lumbar puncture is optional at week 52, except for RMS Cohort Arm 3 and PPMS Cohort. In addition, the lumbar punctures in the Long Term Extension phase is every other year.

DRUG

Methyloprednisolone

Participants will receive 100 mg of IV methylprenisolone (or an equivalent) prior to ocrelizumab infusion.

DRUG

Antihistamine

Participants will receive an antihistamine, such as diphenhydramine, prior to ocrelizumab infusion.

Trial Locations (17)

12210

Empire Neurology, PC, Latham

27599

University of North Carolina at Chapel Hill, Chapel Hill

37075

Universitätsmedizin Göttingen Georg-August-Universität, Göttingen

43210

Ohio State University, Columbus

63110

Washington University; Wash Uni. Sch. Of Med, St Louis

Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr, New York

73104

Oklahoma Medical Research Foundation; MS Center of Excellence, Oklahoma City

80045

University Of Colorado, Aurora

94115

University of California at San Francisco, San Francisco

94303

Stanford University, Palo Alto

06510

Yale University School of Medicine ; Pulmonary & Critical Care, New Haven

01655

University of Massachusetts Medical School, Worcester

75390-0001

University of Texas Southwestern Medical Center, Dallas

V6T 1Z3

University of British Columbia Hospital Site; Djavad Mowafaghian Centre for Brain Health, Vancouver

H3A 2B4

McGill University; Montreal Neurological Institute; Neurological and Psychiatric, Montreal

01307

"Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden", Dresden

113 41

Karolinska Universitetssjukhuset, Solna, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY