Trial Outcomes & Findings for Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis (NCT NCT03396822)

Results Overview

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

1 year

Results posted on

2024-02-28

Participant milestones
Measure	Ocrelizumab Treated Participants treated with ocrelizumab 600mg intravenous every 6 months
Overall Study STARTED	23
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	9

Reasons for withdrawal
Measure	Ocrelizumab Treated Participants treated with ocrelizumab 600mg intravenous every 6 months
Overall Study No meningeal enhancement on baseline scan	8
Overall Study Physician Decision	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Participants With Baseline Meningeal Enhancement n=14 Participants Participants treated with ocrelizumab who had baseline meningeal enhancement
Age, Continuous	47.8 years STANDARD_DEVIATION 2.7 • n=14 Participants
Sex: Female, Male Female	11 Participants n=14 Participants
Sex: Female, Male Male	3 Participants n=14 Participants
Region of Enrollment United States	14 participants n=14 Participants
Meningeal enhancement on baseline scan	14 Participants n=14 Participants

Timeframe: 1 year

Outcome measures
Measure	Participants With Baseline Meningeal Enhancement n=14 Participants Participants treated with ocrelizumab who had baseline meningeal enhancement
Change in the Number of Enhancing Leptomeningeal Foci on 1 Year Follow up Compared to Baseline in MS Patients Treated With Ocrelizumab.	0.07 number of enhancing foci Standard Deviation 2.9

Timeframe: 1 year

Outcome measures
Measure	Participants With Baseline Meningeal Enhancement n=14 Participants Participants treated with ocrelizumab who had baseline meningeal enhancement
Reduction in the Proportion of Participants With Meningeal Enhancement After Treatment With Ocrelizumab Compared to Pre-treatment Baseline.	8 Participants

Timeframe: 1 year

Outcome measures
Measure	Participants With Baseline Meningeal Enhancement n=14 Participants Participants treated with ocrelizumab who had baseline meningeal enhancement
Change in the Volume of Contrast Enhancement on Follow up Compared to Baseline.	-21.9 mm3 Standard Deviation 77.6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Maryland School of Medicine

Phone: 410-328-5605