A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT00676715 |
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Recruitment Status :
Active, not recruiting
First Posted : May 13, 2008
Results First Posted : May 11, 2017
Last Update Posted : November 17, 2020
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Sponsor:
Genentech, Inc.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Multiple Sclerosis, Relapsing-Remitting |
| Interventions |
Drug: Placebo Drug: Ocrelizumab Drug: Avonex |
| Enrollment | 220 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Total 220 participants were randomized, out of which 218 participants received study treatment. |
| Arm/Group Title | Placebo | Ocrelizumab 600 mg | Ocrelizumab 1000 mg | Avonex |
|---|---|---|---|---|
 Arm/Group Description |
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. | 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. | 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. | 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. |
| Period Title: Overall Study | ||||
| Started | 54 | 55 | 55 | 54 |
| Completed | 14 | 8 | 14 | 14 |
| Not Completed | 40 | 47 | 41 | 40 |
| Reason Not Completed | ||||
| Withdrawal by Subject | 7 | 9 | 10 | 10 |
| Other | 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 |
Baseline Characteristics
| Arm/Group Title | Placebo | Ocrelizumab 600 mg | Ocrelizumab 1000 mg | Avonex | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
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. | 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. | 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. | 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 of all reporting groups | |
| Overall Number of Baseline Participants | 54 | 55 | 55 | 54 | 218 | |
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Baseline Analysis Population Description |
The safety population included all participants who received any study drug and underwent at least one assessment of safety.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 54 participants | 55 participants | 55 participants | 54 participants | 218 participants | |
| 38.0 (8.8) | 35.6 (8.5) | 38.5 (8.7) | 38.1 (9.3) | 37.6 (8.8) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 54 participants | 55 participants | 55 participants | 54 participants | 218 participants | |
| Female |
36 66.7%
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35 63.6%
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38 69.1%
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32 59.3%
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141 64.7%
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| Male |
18 33.3%
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20 36.4%
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17 30.9%
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22 40.7%
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77 35.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title: | Medical Communications |
| Organization: | Hoffmann-La Roche |
| Phone: | 800 821-8590 |
| EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00676715 |
| Other Study ID Numbers: |
ACT4422g 2007-006338-32 ( EudraCT Number ) WA21493 ( Other Identifier: Hoffmann-La Roche ) |
| First Submitted: | May 9, 2008 |
| First Posted: | May 13, 2008 |
| Results First Submitted: | March 31, 2017 |
| Results First Posted: | May 11, 2017 |
| Last Update Posted: | November 17, 2020 |