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A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00676715
Recruitment Status : Active, not recruiting
First Posted : May 13, 2008
Results First Posted : May 11, 2017
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
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 March 19, 2019
Actual Study Start Date  ICMJE July 31, 2008
Actual Primary Completion Date March 9, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
Total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain [ Time Frame: Weeks 12, 16, 20 and 24 ]
Change History Complete list of historical versions of study NCT00676715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
  • The annualized protocol defined relapse rate [ Time Frame: Week 24 ]
  • Proportion of patients who remain relapse-free [ Time Frame: Week 24 ]
  • Change in total volume of T2 lesions on MRI scans of the brain [ Time Frame: Baseline to week 24 ]
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
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE
  • 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
  • Drug: Ocrelizumab
    Ocrelizumab 1000 mg IV infusions was administered on cycle 1 Day 1.
    Other Name: RO4964913
  • 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
  • Drug: Avonex
    Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
    Other Name: Interferon-beta-alpha1
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Ocrelizumab
  • 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.
    Intervention: Drug: Ocrelizumab
  • 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.
    Intervention: Drug: Ocrelizumab
  • 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.
    Interventions:
    • Drug: Ocrelizumab
    • Drug: Avonex
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.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 31, 2017)
220
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2008)
250
Estimated Study Completion Date  ICMJE December 9, 2021
Actual Primary Completion Date March 9, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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,   Finland,   France,   Germany,   Italy,   Mexico,   Netherlands,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00676715
Other Study ID Numbers  ICMJE ACT4422g
2007-006338-32 ( EudraCT Number )
WA21493 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP