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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 : September 25, 2019
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Placebo Drug: Ocrelizumab Drug: Avonex Phase 2

Study Design
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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 31, 2008
Actual Primary Completion Date : March 9, 2012
Estimated Study Completion Date : December 9, 2021

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Placebo
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.

Drug: Ocrelizumab
Two infusion 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.
Other Name: RO4964913
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.
 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.
 Drug: Ocrelizumab
Ocrelizumab 1000 mg IV infusions was administered on cycle 1 Day 1.
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.
 Drug: Ocrelizumab
Two infusion 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.
Other Name: RO4964913

Drug: Avonex
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Other Name: Interferon-beta-alpha1


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Annualized Protocol Defined Relapse Rate at Week 24 [ Time Frame: Week 24 ]
    Adjusted annualized relapse rate for geographical region.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


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Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00676715     History of Changes
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: September 25, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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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
 Interferon-beta
Interferon beta-1a
Ocrelizumab
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic