A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
NCT ID: NCT02545868
Last Updated: 2024-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
102 participants
INTERVENTIONAL
2015-10-27
2021-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A: OCR + Vaccines
Participants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period.
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).
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).
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).
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).
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.
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).
Group B: Vaccines (Optional OCR in Extension)
Participants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
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).
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).
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).
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.
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).
Interventions
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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).
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).
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).
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).
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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
* Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive
* For sexually active female participants of reproductive potential, use of reliable means of contraception
Exclusion Criteria
* Known presence of other neurologic disorders
* Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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North Central Neurology Associates
Cullman, Alabama, United States
Territory Neurology and Research Institute
Tucson, Arizona, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Scripps Clinic
La Jolla, California, United States
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Mercy Hospital St. Louis / Mercy Clinic Neurology
Chesterfield, Missouri, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States
University of New Mexico
Albuquerque, New Mexico, United States
Staten Island Univ Hospital
Staten Island, New York, United States
Neurology Associates PA
Hickory, North Carolina, United States
Ohio Health Research Institute Grant Medical Center
Columbus, Ohio, United States
MDH Research LLC
Westerville, Ohio, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Neurology Clinic PC
Cordova, Tennessee, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Rocky Mountain MS Clinic
Salt Lake City, Utah, United States
Swedish Medical Center
Seattle, Washington, United States
University of Calgary
Calgary, Alberta, Canada
University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, Canada
Countries
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References
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Bar-Or A, Calkwood JC, Chognot C, Evershed J, Fox EJ, Herman A, Manfrini M, McNamara J, Robertson DS, Stokmaier D, Wendt JK, Winthrop KL, Traboulsee A. Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study. Neurology. 2020 Oct 6;95(14):e1999-e2008. doi: 10.1212/WNL.0000000000010380. Epub 2020 Jul 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001357-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BN29739
Identifier Type: -
Identifier Source: org_study_id
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