A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 220 participants were randomized, out of which 218 participants received study treatment.

Reporting Groups

	Description
Placebo	Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 600 mg	Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 1000 mg	Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
Avonex	Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

Participant Flow:   Overall Study

	Placebo	Ocrelizumab 600 mg	Ocrelizumab 1000 mg	Avonex
STARTED	54	55	55	54
COMPLETED	14	8	14	14
NOT COMPLETED	40	47	41	40
Withdrawal by Subject	7	9	10	10
Unspecified	2	6	4	3
Lost to Follow-up	1	1	7	3
Death	1	1	1	0
Adverse Event	0	1	2	0
Participants Ongoing	29	29	17	24

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any study drug and underwent at least one assessment of safety.

Reporting Groups

	Description
Placebo	Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 600 mg	Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab 1000 mg	Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
Avonex	Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Ocrelizumab 600 mg	Ocrelizumab 1000 mg	Avonex	Total
Overall Participants Analyzed  [Units: Participants]	54	55	55	54	218
Age  [Units: Years] Mean (Standard Deviation)	38.0  (8.8)	35.6  (8.5)	38.5  (8.7)	38.1  (9.3)	37.6  (8.8)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	36  66.7%	35  63.6%	38  69.1%	32  59.3%	141  64.7%
Male	18  33.3%	20  36.4%	17  30.9%	22  40.7%	77  35.3%

1.  Primary:

Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain   [ Time Frame: Week 12 to Week 24 ]

2.  Secondary:

Annualized Protocol Defined Relapse Rate at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:

Percentage of Participants Who Remained Relapse Free at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:

Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:

Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain   [ Time Frame: Weeks 4 to Week 24 ]

6.  Secondary:

Total Number of Gadolinium-Enhancing T1 Lesions at Weeks   [ Time Frame: Weeks 4 to Week 24 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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