NCT02545868|CompletedPhase 3ResultsFDA Drug

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

A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis

Hoffmann-La Roche ClinicalTrials.gov

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2 other identifiers

BN297392015-001357-32

Study Type

interventional

Target

102

Locations

2 countries

Sites

Timeline

RegisteredSep 2015

StartedOct 2015

CompletionSep 2021

Brief Summary

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza vaccine, keyhole limpet hemocyanin \[KLH\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

102

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2015

Longer than P75 for phase_3

Geographic Reach

2 countries

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

First Submitted

Initial submission to the registry

September 8, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed

2 months until next milestone

Study Start

First participant enrolled

October 27, 2015

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

June 6, 2018

Completed

3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed

Last Updated

March 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

September 8, 2015

Results QC Date

February 13, 2018

Last Update Submit

February 29, 2024

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
8 weeks after TT vaccine

Secondary Outcomes (31)

Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
4 weeks after TT vaccine
Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
4 weeks after TT vaccine
Mean Levels of Anti-Tetanus Antibody
Immediately prior to and at 4 and 8 weeks after TT vaccine
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Mean Levels of Anti-KLH Antibody: Ig M
Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
+26 more secondary outcomes

Study Arms (2)

Group A: OCR + Vaccines

EXPERIMENTAL

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.

Biological: 23-PPVBiological: 13-PCV BoosterBiological: Influenza VaccineBiological: KLHDrug: OCRBiological: TT Vaccine

Group B: Vaccines (Optional OCR in Extension)

OTHER

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.

Biological: 23-PPVBiological: Influenza VaccineBiological: KLHDrug: OCRBiological: TT Vaccine

Interventions

23-PPVBIOLOGICAL

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).