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Trial record 1 of 1 for:    NCT01412333
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A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01412333
First received: August 8, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis. Patients will be randomized to receive either in group A, ocrelizumab 600 mg intravenously (iv) every 24 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, Rebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc three times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Drug: ocrelizumab
Drug: Rebif
Drug: ocrelizumab placebo
Drug: Rebif placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Annualized protocol-defined relapse rate by 2 years in patients with relapsing MS [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of sustained disability progression for at least 12 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to onset of sustained disability progression for at least 24 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of relapse-free patients [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Change in total T2 lesion volume as detected by brain MRI [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change in Multiple Sclerosis Functional Composite Scale (MSFCS) score [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Change in brain volume as detected by brain MRI [ Time Frame: from Week 24 to Week 96 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Exposure to ocrelizumab (area under the concentration - time curve) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity: Human anti-human antibodies (HAHA) levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: September 2011
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: ocrelizumab
600 mg iv every 24 weeks (dual infusions of 300 mg on Day 1 and 15 of Cycle 1, single infusion of 600 mg on Day 1 of each following cycle), 96 weeks
Drug: Rebif placebo
Rebif dummy placebo sc according to schedule in Rebif active group B
Active Comparator: B Drug: Rebif
8.8 mcg (Weeks 1+2) / 22 mcg (Weeks 3+4) / 44mcg (Week 5 and following) subcutaneously 3 times weekly, 96 weeks
Other Name: Rebif
Drug: ocrelizumab placebo
Ocrelizumab dummy placebo iv according to schedule in ocrelizumab active group A

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 18-55 years of age inclusive
  • Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
  • Neurologic stability for >/= 30 days prior to both screening and baseline
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in patients with EDSS </= 2.0 at screening
  • Contraindications for MRI
  • Known presence of other neurological disorders which may mimic multiple sclerosis
  • Pregnancy or lactation
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis)
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or iv corticosteroids
  • Contraindications to Rebif or incompatibility with Rebif use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412333

Contacts
Contact: Please reference Study ID Number: WA21093 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 217 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01412333     History of Changes
Other Study ID Numbers: WA21093
Study First Received: August 8, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 21, 2013