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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Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis, Relapsing-Remitting | Drug: Placebo Drug: Ocrelizumab Drug: Avonex | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 17, 2008 |
Actual Primary Completion Date : | March 9, 2012 |
Estimated Study Completion Date : | December 16, 2023 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Participants received two intravenous (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.
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Drug: Placebo
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1. |
Experimental: Ocrelizumab 600 mg
Participants 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.
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Drug: Ocrelizumab
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
Other Name: RO4964913 |
Experimental: 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.
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Drug: Ocrelizumab
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
Other Name: RO4964913 |
Active Comparator: Avonex
Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 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.
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Drug: Avonex
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Other Name: Interferon-beta-alpha1 |
- 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.
- Annualized Protocol Defined Relapse Rate at Week 24 [ Time Frame: Week 24 ]Adjusted annualized relapse rate for geographical region.
- Percentage of Participants Who Remained Relapse Free at Week 24 [ Time Frame: Week 24 ]Percentage of participants who remained relapse free at week 24 were reported.
- Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24 [ Time Frame: Baseline, Week 24 ]Change from baseline in total volume of T2 lesions on MRI scans of the Brain at week 24 was reported.
- Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain [ Time Frame: Weeks 4 to Week 24 ]Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.
- Total Number of Gadolinium-Enhancing T1 Lesions at Weeks [ Time Frame: Weeks 4 to Week 24 ]Total number of gadolinium-enhancing T1 lesions at weeks were reported.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- Relapsing-remitting multiple sclerosis (MS)
- Ages 18-55 years inclusive
- For sexually active female and male participants of reproductive potential, use of reliable means of contraception
Exclusion Criteria:
- Secondary or primary progressive multiple sclerosis at screening
- Incompatibility with MRI
- Contra-indications to or intolerance of oral or IV corticosteroids
- Known presence of other neurologic disorders
- Pregnancy or lactation
- Lack of peripheral venous access
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
- History or known presence of recurrent or chronic infection
- History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
- History of alcohol or drug abuse within 24 weeks prior to randomization
- History of or currently active primary or secondary immunodeficiency
- History of coagulation disorders
- Treatment with any investigational agent within 4 weeks of screening
- Receipt of a live vaccine within 6 weeks prior to randomization
- Incompatibility with Avonex use
- Previous treatment with rituximab
- Previous treatment with lymphocyte-depleting therapies except mitoxantrone
- Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
- Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
- Systemic corticosteroid therapy within 4 weeks prior to randomization

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676715

Study Director: | Clinical Trials | Genentech, Inc. |
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 Posted: | May 13, 2008 Key Record Dates |
Results First Posted: | May 11, 2017 |
Last Update Posted: | January 17, 2023 |
Last Verified: | January 2023 |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Interferons Interferon-beta Ocrelizumab Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |