A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00676715 |
Recruitment Status :
Active, not recruiting
First Posted : May 13, 2008
Results First Posted : May 11, 2017
Last Update Posted : January 17, 2023
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Sponsor:
Genentech, Inc.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | May 9, 2008 | |||
First Posted Date ICMJE | May 13, 2008 | |||
Results First Submitted Date ICMJE | March 31, 2017 | |||
Results First Posted Date ICMJE | May 11, 2017 | |||
Last Update Posted Date | January 17, 2023 | |||
Actual Study Start Date ICMJE | July 17, 2008 | |||
Actual Primary Completion Date | March 9, 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain [ Time Frame: Week 12 to Week 24 ] Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
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Original Primary Outcome Measures ICMJE |
Total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain [ Time Frame: Weeks 12, 16, 20 and 24 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | |||
Official Title ICMJE | Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS | |||
Brief Summary | This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis, Relapsing-Remitting | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
220 | |||
Original Estimated Enrollment ICMJE |
250 | |||
Estimated Study Completion Date ICMJE | December 16, 2023 | |||
Actual Primary Completion Date | March 9, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Italy, Mexico, Romania, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Ukraine, United Kingdom, United States | |||
Removed Location Countries | Czech Republic, Finland, Netherlands | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00676715 | |||
Other Study ID Numbers ICMJE | ACT4422g 2007-006338-32 ( EudraCT Number ) WA21493 ( Other Identifier: Hoffmann-La Roche ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Genentech, Inc. | |||
Original Responsible Party | Clinical Trials Posting Group, Genentech, Inc. | |||
Current Study Sponsor ICMJE | Genentech, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Roche Pharma AG | |||
Investigators ICMJE |
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PRS Account | Genentech, Inc. | |||
Verification Date | January 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |