Trial Outcomes & Findings for Short-term B-cell Depletion in Relapsing Multiple Sclerosis (NCT NCT03853746)

Last Updated: 2025-02-05

Results Overview

Number of patients with a return of disease activity after the third month post-first-infusion, objectively demonstrated by development of new T2 hyperintense lesions or Gd-enhancing lesions on the MRI or a clinical relapse that is confirmed with an objective change in the neurological examination.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

27 months

Results posted on

2025-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Ocrelizumab All participants will receive Ocrelizumab Ocrelizumab: Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ocrelizumab All participants will receive Ocrelizumab Ocrelizumab: Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

One participant dropped out immediately after signing the informed consent form and was not included in the subsequent analyses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocrelizumab n=9 Participants All participants will receive Ocrelizumab Ocrelizumab: Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
Age, Continuous	29.3 years STANDARD_DEVIATION 9.9 • n=5 Participants • One participant dropped out immediately after signing the informed consent form and was not included in the subsequent analyses.
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Expanded Diability Status Scale	2 points n=5 Participants
Participants Who Received Prior Disease Modifying Therapy No medication	7 Count n=5 Participants
Participants Who Received Prior Disease Modifying Therapy Glatiramer	2 Count n=5 Participants
Disease Duration	2.9 years STANDARD_DEVIATION 4.2 • n=5 Participants

PRIMARY outcome

Timeframe: 27 months

Outcome measures

Outcome measures
Measure	Ocrelizumab n=9 Participants All participants will receive Ocrelizumab Ocrelizumab: Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
Number of Patients With a Return of Disease Activity After the Third Month Post-first-infusion Participants who experienced a return of disease activity	3 Participants
Number of Patients With a Return of Disease Activity After the Third Month Post-first-infusion Participants who did not experience a return of disease activity	6 Participants

SECONDARY outcome

Timeframe: Every 6 months, up to 30 months

EDSS scores range from 0 to 10, with 0.5 steps. The higher the score, the worse the MS-related disability. Although the outcome was measured every six months, we used a linear mixed-effects model to analyze the data. The coefficient from this model represents the change in the outcome per unit of time (month), allowing for a consistent interpretation of the rate of change.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=9 Participants All participants will receive Ocrelizumab Ocrelizumab: Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
Change in Disability as Assessed by Expanded Disability Status Scale (EDSS)	-0.009 Points change per month Interval -0.0183 to -0.0004

SECONDARY outcome

Timeframe: Every 6 months, up to 30 months

The CAT produces a T-score (standardized score with a mean of 50 and a standard deviation (SD) of 10). A higher Neuro-QoL T-score represents more of the concept being measured. Here is the change in score from baseline to month 30. Although the outcome was measured every six months, we used a linear mixed-effects model to analyze the data. The coefficient from this model represents the change in the outcome per unit of time (month), allowing for a consistent interpretation of the rate of change.

Outcome measures

Outcome measures
Measure	Ocrelizumab n=9 Participants All participants will receive Ocrelizumab Ocrelizumab: Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
Change in a Quality of Life Measure as Assessed by Neuro-QoL Computer Adaptive Test (CAT) Fatigue Test	-0.012 point chnage per month Interval -0.15 to 0.12

Adverse Events

Ocrelizumab

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ocrelizumab n=9 participants at risk All participants will receive Ocrelizumab Ocrelizumab: Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
Respiratory, thoracic and mediastinal disorders Congestion	11.1% 1/9 • Number of events 1 • Post last ocrelizumab treatment up to 24 months
Skin and subcutaneous tissue disorders Hives	11.1% 1/9 • Number of events 1 • Post last ocrelizumab treatment up to 24 months
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Post last ocrelizumab treatment up to 24 months
Nervous system disorders Fatigue	11.1% 1/9 • Number of events 1 • Post last ocrelizumab treatment up to 24 months
Respiratory, thoracic and mediastinal disorders Bronchitis	11.1% 1/9 • Number of events 1 • Post last ocrelizumab treatment up to 24 months
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Number of events 1 • Post last ocrelizumab treatment up to 24 months

Additional Information

Bardia Nourbakhsh

Johns Hopkins Universtiy

Phone: 410-614-1522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place