A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Public ClinicalTrials.gov record NCT01247324. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.
Study identification
- NCT ID
- NCT01247324
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 821 participants
Conditions and interventions
Conditions
Interventions
- Interferon beta-1a Drug
- Ocrelizumab-matching placebo Drug
- Ocrelizumab Drug
- Interferon beta-1a-matching placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011 (Actual)
- Primary completion
- Apr 2, 2015 (Actual)
- Completion
- Dec 31, 2022 (Actual)
- Last update posted
- Mar 4, 2024
2011 – 2022
United States locations
- U.S. sites
- 40
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 21st Century Neurology | Phoenix | Arizona | 85004 | — |
| Mercy Medical Group | Carmichael | California | 95608 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| MS Center of California | Laguna Hills | California | 92653 | — |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | — |
| Neuro-Therapeutics Inc. | Pasadena | California | 91105 | — |
| University of California at San Francisco | San Francisco | California | 94115 | — |
| Health First Physicians Inc. | Melbourne | Florida | 32901 | — |
| Mercy Research Institute | Miami | Florida | 33133 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Shepherd Center Inc. | Atlanta | Georgia | 30309 | — |
| Emory University; Department of Neurology | Atlanta | Georgia | 30322 | — |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30342 | — |
| Northwestern University; Dept. of Neurology | Chicago | Illinois | 60611 | — |
| Consultants in Neurology Ltd | Northbrook | Illinois | 60062 | — |
| American Health Network Institute, LLC | Avon | Indiana | 46123 | — |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | — |
| Michigan Neurology Associates P.C. | Clinton Township | Michigan | 48035 | — |
| Michigan Institute for Neurological Disorders | Farmington Hills | Michigan | 48334 | — |
| The Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | — |
| Washington University; Wash Uni. Sch. Of Med | St Louis | Missouri | 63110 | — |
| The MS Center for Innovations In Care | St Louis | Missouri | 63131 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-0600 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| The MS Center; Advance Neurology and Pain | Advance | North Carolina | 27006 | — |
| Atrium Health Neurosciences Institute ? Charlotte | Charlotte | North Carolina | 28204 | — |
| OnSite Clinical Solutions LLC | Charlotte | North Carolina | 28277 | — |
| Neurology Associates PA | Hickory | North Carolina | 28602 | — |
| University Neurology Inc. | Cincinnati | Ohio | 45219 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| Providence Neurological Specialties | Portland | Oregon | 97225 | — |
| Albert Einstein Medical Center; Depatment of Neurosensory sciences | Philadelphia | Pennsylvania | 19141 | — |
| Magee-Woman's Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Uni of Texas Health Science Center At Houston | Houston | Texas | 77030 | — |
| Bhupesh Dihenia M.D. P.A. | Lubbock | Texas | 79410 | — |
| Uni of Vermont Medical Center; | Burlington | Vermont | 05405 | — |
| Multicare Research Institute; Multicare Neuroscience Center of Washington | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01247324, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01247324 live on ClinicalTrials.gov.