Trial Outcomes & Findings for Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis (NCT NCT04261790)
NCT ID: NCT04261790
Last Updated: 2025-02-17
Results Overview
By assessing the antibodies produced by isolated B-cells, changes in the frequencies (percentage) of polyreactive, and anti-nuclear clones of new emigrant/transitional and mature naive B-cells will be determined.
COMPLETED
PHASE4
10 participants
Baseline and 18-24 months
2025-02-17
Participant Flow
Participant milestones
| Measure |
Ocrelizumab
Patients 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 the return of the disease activity can go back on the medication.
Ocrelizumab: Patients will be treated with two courses of ocrelizumab (Ocrevus) 600mg/course, for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience the return of the disease activity can go back on the medication.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Ocrelizumab
n=10 Participants
Patients 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 the return of the disease activity can go back on the medication.
Ocrelizumab: Patients will be treated with two courses of ocrelizumab (Ocrevus) 600mg/course, for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience the return of the disease activity can go back on the medication.
|
|---|---|
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Age, Continuous
|
36 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Disease Duration
|
2.8 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
|
Baseline Expanded Disability Status Scale (EDSS)
|
1.0 units on a scale
n=99 Participants
|
|
Disease-modifying Therapy (DMT) at Screening
No DMT
|
8 Participants
n=99 Participants
|
|
Disease-modifying Therapy (DMT) at Screening
Glatiramer acetate
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 18-24 monthsPopulation: Data were not collected. None of the antibodies from the immune cells were able to cloned for analysis and no data were collected from the lab samples.
By assessing the antibodies produced by isolated B-cells, changes in the frequencies (percentage) of polyreactive, and anti-nuclear clones of new emigrant/transitional and mature naive B-cells will be determined.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 18-24 monthsPopulation: Data were not collected. None of the antibodies from the immune cells were able to cloned for analysis and no data were collected from the lab samples.
Change in the frequency (percentage) of different B-cell subpopulation (assessed by flow cytometry) before and after treatment with ocrelizumab.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 18-24 monthsPopulation: Data were not collected. None of the antibodies from the immune cells were able to cloned for analysis and no data were collected from the lab samples.
Change in the frequency (percentage) of different T-cells subpopulation (assessed by flow cytometry) before and after treatment with ocrelizumab.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 18-24 monthsPopulation: Data were not collected. None of the antibodies from the immune cells were able to cloned for analysis and no data were collected from the lab samples.
Pro inflammatory cytokines, produced by Tregs and other T cell subsets after activating peripheral blood mononucleated cell with phorbol-12-myristate-13-acetate (PMA) and ionomycin will be measured by enzyme-linked immunosorbent assay.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 18-24 monthsPopulation: Data were not collected. None of the antibodies from the immune cells were able to cloned for analysis and no data were collected from the lab samples.
Anti-inflammatory cytokines, produced by Tregs and other T cell subsets after activating peripheral blood mononucleated cell with phorbol-12-myristate-13-acetate (PMA) and ionomycin will be measured by enzyme-linked immunosorbent assay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 monthsPatients with the 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.
Outcome measures
| Measure |
Ocrelizumab
n=10 Participants
Ocrelizumab group
|
|---|---|
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Patients With Return of Disease Activity
Participants who experienced the return of disease activity during the 30-month trial
|
0 Participants
|
|
Patients With Return of Disease Activity
Participants who did not experience the return of disease activity during the 30-month trial
|
10 Participants
|
SECONDARY outcome
Timeframe: Screening visit and month 30 visitEDSS scores range from 0 to 10, with 0.5 steps. The higher the score, the worse the MS-related disability.
Outcome measures
| Measure |
Ocrelizumab
n=10 Participants
Ocrelizumab group
|
|---|---|
|
Change in Disability as Assessed by Expanded Disability Status Scale (EDSS)
|
-0.5 units on a scale
Standard Deviation 6.0
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SECONDARY outcome
Timeframe: Screening visit and month 30 visitT-score (standardized scores 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. There is no specific upper or lower limit for this scoring
Outcome measures
| Measure |
Ocrelizumab
n=10 Participants
Ocrelizumab group
|
|---|---|
|
Change in Quality of Life as Assessed by Neuro-QoL Fatigue T-score
|
2.6 units on a scale
Standard Deviation 5.0
|
Adverse Events
Ocrelizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ocrelizumab
n=10 participants at risk
Ocrelizumab group
|
|---|---|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 3 • Participants received two courses of treatment with ocrelizumab six months apart. Adverse event data were collected up to 24 months after the second (last) ocrelizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • Participants received two courses of treatment with ocrelizumab six months apart. Adverse event data were collected up to 24 months after the second (last) ocrelizumab infusion.
|
|
Cardiac disorders
Chest discomfort
|
10.0%
1/10 • Number of events 1 • Participants received two courses of treatment with ocrelizumab six months apart. Adverse event data were collected up to 24 months after the second (last) ocrelizumab infusion.
|
|
Vascular disorders
Blood pressure fluctuation
|
10.0%
1/10 • Number of events 1 • Participants received two courses of treatment with ocrelizumab six months apart. Adverse event data were collected up to 24 months after the second (last) ocrelizumab infusion.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place