Trial Outcomes & Findings for Mechanism of Action of Ocrelizumab in Multiple Sclerosis (NCT NCT03344094)

Last Updated: 2025-02-21

Results Overview

measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy Mononuclear cells (MNC) will be stained, for flow cytometry, with marker antibodies to B cells. The change in the percentage of each subset will be compared before and after treatment with paired t tests and ANOVA.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

1 year

Results posted on

2025-02-21

Participant Flow

began 2-23-2018; filled 3-9-2018

not needed

Participant milestones

Participant milestones
Measure	MS-ocrelizumab Treated ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start ocrelizumab: FDA-approved MS drugs	MS Untreated age- and sex-matched untreated MS controls	Healthy Control age- and sex-matched untreated healthy controls	MS Interferon-treated MS with ongoing interferon-beta therapy
Overall Study STARTED	15	5	5	5
Overall Study COMPLETED	15	5	5	5
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanism of Action of Ocrelizumab in Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MS-ocrelizumab Treated n=15 Participants ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start ocrelizumab: FDA-approved MS drugs	MS Untreated n=5 Participants age- and sex-matched untreated MS controls	Healthy Control n=5 Participants age- and sex-matched untreated healthy controls	MS Interferon-treated n=5 Participants MS with ongoing interferon-beta therapy	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	27 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Age, Continuous	47.7 years STANDARD_DEVIATION 14.3 • n=5 Participants	48.5 years STANDARD_DEVIATION 14.8 • n=7 Participants	55.1 years STANDARD_DEVIATION 13.7 • n=5 Participants	41.8 years STANDARD_DEVIATION 2.5 • n=4 Participants	48.4 years STANDARD_DEVIATION 13.8 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	15 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	30 participants n=21 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The MS-ocrelizumab treated group was analyzed for depletion of B cells, whereas MS-untreated, healthy controls and MS interferon-treated groups were not analyzed for depletion of B cells.

Outcome measures

Outcome measures
Measure	MS Interferon-treated MS with ongoing interferon-beta therapy all enrolled	MS-ocrelizumab Treated n=15 Participants ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start ocrelizumab: FDA-approved MS drugs all enrolled	MS Untreated age- and sex-matched untreated MS controls all enrolled	Healthy Control age- and sex-matched untreated healthy controls all enrolled
Number of Participants With Complete Depletion of B Cells	0 Participants	15 Participants	0 Participants	0 Participants

Adverse Events

MS-ocrelizumab Treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MS Untreated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MS Interferon-treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

anthony t reder

University of Chicago

Phone: 773-702-6204

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place