Trial Outcomes & Findings for Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease. (NCT NCT04877457)
NCT ID: NCT04877457
Last Updated: 2024-10-09
Results Overview
The primary efficacy endpoint for this study is to evaluate the efficacy of ocrelizumab compared with placebo on delaying the time to development of new radiological or clinical evidence of MS, defined as the time from baseline to first new T1 gadolinium-enhancing lesions and/or new or enlarging T2 lesions consistent with MS in participants OR first clinical evidence of MS, i.e., neurological event resulting from CNS demyelination as evidenced by acute or progressive clinical syndrome consistent with MS in participants.
TERMINATED
PHASE4
3 participants
Up 4 years
2024-10-09
Participant Flow
Participant milestones
| Measure |
Ocrelizumab - Participants Without a First Degree Family Member With Multiple Sclerosis
Three courses of ocrelizumab will be administered over the course of the study.
Ocrelizumab: The first course of ocrelizumab will be administered as two 300 mg infusions at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given as a single 600 mg infusion at Weeks 24 and 48.
|
Placebo - Participants Without a First Degree Family Member With Multiple Sclerosis.
Three courses of placebo will be administered over the course of the study.
Placebo: Placebo will be administered at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given at Weeks 24 and 48.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ocrelizumab - Participants Without a First Degree Family Member With Multiple Sclerosis
Three courses of ocrelizumab will be administered over the course of the study.
Ocrelizumab: The first course of ocrelizumab will be administered as two 300 mg infusions at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given as a single 600 mg infusion at Weeks 24 and 48.
|
Placebo - Participants Without a First Degree Family Member With Multiple Sclerosis.
Three courses of placebo will be administered over the course of the study.
Placebo: Placebo will be administered at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given at Weeks 24 and 48.
|
|---|---|---|
|
Overall Study
Early termination of study due to low enrollment
|
2
|
1
|
Baseline Characteristics
Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.
Baseline characteristics by cohort
| Measure |
Ocrelizumab
n=2 Participants
Three courses of ocrelizumab will be administered over the course of the study.
Ocrelizumab: The first course of ocrelizumab will be administered as two 300 mg infusions at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given as a single 600 mg infusion at Weeks 24 and 48.
|
Placebo
n=1 Participants
Three courses of placebo will be administered over the course of the study.
Placebo: Placebo will be administered at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given at Weeks 24 and 48.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 Years
n=5 Participants
|
35 Years
n=7 Participants
|
33 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoking status
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
History of infectious mononucleosis
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
History of childhood/adolescent obesity
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of participants with a family history of MS
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up 4 yearsPopulation: Data not collected due to early termination of study
The primary efficacy endpoint for this study is to evaluate the efficacy of ocrelizumab compared with placebo on delaying the time to development of new radiological or clinical evidence of MS, defined as the time from baseline to first new T1 gadolinium-enhancing lesions and/or new or enlarging T2 lesions consistent with MS in participants OR first clinical evidence of MS, i.e., neurological event resulting from CNS demyelination as evidenced by acute or progressive clinical syndrome consistent with MS in participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Data for this outcome was not collected.
MRI scans will be used to determine the number of new or enlarging T2 lesions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeksPopulation: Data for this outcome was not collected.
MRI scans will be used to the change in T2 lesions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Data for this outcome was not collected.
MRI scans will be used to determine the cumulative number of new T1 gadolinium-enhancing lesions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeksPopulation: Data for this outcome was not collected.
MRI scan will be used to determine the change in total brain volume
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeksPopulation: Data for this outcome was not collected.
MRI scan will be used to determine the change in total brain volume
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 130 weeks, 156 weeks, 182 weeks, 208 weeksPopulation: Data for this outcome was not collected.
Change in serum Nfl will be used measured
Outcome measures
Outcome data not reported
Adverse Events
Ocrelizumab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ocrelizumab
n=2 participants at risk
Three courses of ocrelizumab will be administered over the course of the study.
Ocrelizumab: The first course of ocrelizumab will be administered as two 300 mg infusions at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given as a single 600 mg infusion at Weeks 24 and 48.
|
Placebo
n=1 participants at risk
Three courses of placebo will be administered over the course of the study.
Placebo: Placebo will be administered at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given at Weeks 24 and 48.
|
|---|---|---|
|
General disorders
Positional headache
|
0.00%
0/2 • The period of time over which adverse event data were collected was over one year.
All adverse events were not study-drug related. The total number of subjects therefore not at risk for the adverse events that occurred and were reported.
|
100.0%
1/1 • Number of events 1 • The period of time over which adverse event data were collected was over one year.
All adverse events were not study-drug related. The total number of subjects therefore not at risk for the adverse events that occurred and were reported.
|
|
Eye disorders
Blurry vision
|
0.00%
0/2 • The period of time over which adverse event data were collected was over one year.
All adverse events were not study-drug related. The total number of subjects therefore not at risk for the adverse events that occurred and were reported.
|
100.0%
1/1 • Number of events 1 • The period of time over which adverse event data were collected was over one year.
All adverse events were not study-drug related. The total number of subjects therefore not at risk for the adverse events that occurred and were reported.
|
|
Ear and labyrinth disorders
Left ear infection
|
50.0%
1/2 • Number of events 1 • The period of time over which adverse event data were collected was over one year.
All adverse events were not study-drug related. The total number of subjects therefore not at risk for the adverse events that occurred and were reported.
|
0.00%
0/1 • The period of time over which adverse event data were collected was over one year.
All adverse events were not study-drug related. The total number of subjects therefore not at risk for the adverse events that occurred and were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place