A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

October 27, 2015

Primary Completion Date

February 14, 2017

Study Completion Date

September 21, 2021

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
BIOLOGICAL

23-PPV

The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).

BIOLOGICAL

13-PCV Booster

The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).

BIOLOGICAL

Influenza Vaccine

The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).

BIOLOGICAL

KLH

KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).

DRUG

OCR

OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.

BIOLOGICAL

TT Vaccine

The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).

Trial Locations (22)

10306

Staten Island Univ Hospital, Staten Island

19001

Abington Neurological Associates, Abington

28602

Neurology Associates PA, Hickory

33136

University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center, Miami

33612

University of South Florida, Tampa

35058

North Central Neurology Associates, Cullman

38018

Neurology Clinic PC, Cordova

43082

MDH Research LLC, Westerville

43214

Ohio Health Research Institute Grant Medical Center, Columbus

48334

Michigan Institute for Neurological Disorders, Farmington Hills

55422

The Minneapolis Clinic of Neurology, Golden Valley

63017

Mercy Hospital St. Louis / Mercy Clinic Neurology, Chesterfield

78681

Central Texas Neurology Consultants, Round Rock

84103

Rocky Mountain MS Clinic, Salt Lake City

85704

Territory Neurology and Research Institute, Tucson

87131

University of New Mexico, Albuquerque

89106

Cleveland Clinic Lou Ruvo; Center for Brain Research, Las Vegas

92037

Scripps Clinic, La Jolla

92835

Fullerton Neurology and Headache Center, Fullerton

98104-1360

Swedish Medical Center, Seattle

T2N 2T9

University of Calgary, Calgary

V6T 2B5

University of British Columbia Hospital; Division of Neurology, Vancouver

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02545868 - A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis | Biotech Hunter | Biotech Hunter