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A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01412333
First received: August 8, 2011
Last updated: October 25, 2016
Last verified: October 2016

August 8, 2011
October 25, 2016
September 2011
May 2015   (Final data collection date for primary outcome measure)
Annualized Protocol-defined Relapse Rate at 96 Weeks [ Time Frame: 96 weeks ]
Relapse rate: Occurrence of new or worsening neurological symptoms, as defined by protocol [ Time Frame: 96 weeks ]
Complete list of historical versions of study NCT01412333 on ClinicalTrials.gov Archive Site
  • Time to Onset of Confirmed Disability Progression for at least 12 weeks as Assessed by Expanded Disability Status Scale (EDSS) Score [ Time Frame: 96 weeks ]
    Confirmed disability progression is to be confirmed for at least 12 weeks after the initial event of neurological worsening occurring during the 96-week treatment period.
  • Total Number of T1 Gadolinium Enhanced Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Weeks 24, 48, and 96 ]
  • Total Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ]
  • Percentage of Participants With Confirmed Disability Improvement for at least 12 weeks as Assessed by EDSS Score [ Time Frame: 96 weeks ]
    Confirmed disability improvement for at least 12 weeks with the initial event of neurological improvement occurring during the 96-week treatment period.
  • Time to Onset of Confirmed Disability Progression for at least 24 weeks as Assessed by EDSS Score [ Time Frame: 96 weeks ]
    Confirmed disability progression is to be confirmed for at least 24 weeks after the initial event of neurological worsening occurring during the 96-week treatment period.
  • Total Number of New T1-Hypointense Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ]
  • Change From Baseline in Multiple Sclerosis Functional Composite Scale (MSFCS) Score at Week 96 [ Time Frame: Baseline, Week 96 ]
  • Percentage Change in Brain Volume as Detected by Brain MRI From Week 24 to Week 96 [ Time Frame: Week 24, Week 96 ]
  • Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) Score at Week 96 [ Time Frame: Baseline, Week 96 ]
  • Percentage of Participants With no Evidence of Disease Activity (NEDA) at Week 96 as Assessed by Neurological Symptoms and MRI [ Time Frame: Week 96 ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 96 ]
  • Exposure to Ocrelizumab (Area Under the Concentration - Time Curve) [ Time Frame: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Week 84 and 96 visits ]
  • Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab [ Time Frame: Baseline up to Week 96 ]
  • Time to onset of sustained disability progression for at least 12 weeks [ Time Frame: 96 weeks ]
  • Time to onset of sustained disability progression for at least 24 weeks [ Time Frame: 96 weeks ]
  • Proportion of relapse-free patients [ Time Frame: Week 96 ]
  • Change in total T2 lesion volume as detected by brain MRI [ Time Frame: from baseline to Week 96 ]
  • Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI [ Time Frame: 96 weeks ]
  • Change in Multiple Sclerosis Functional Composite Scale (MSFCS) score [ Time Frame: from baseline to Week 96 ]
  • Change in brain volume as detected by brain MRI [ Time Frame: from Week 24 to Week 96 ]
  • Safety: Incidence of adverse events [ Time Frame: 120 weeks ]
  • Pharmacokinetics: Exposure to ocrelizumab (area under the concentration - time curve) [ Time Frame: 96 weeks ]
  • Immunogenicity: Human anti-human antibodies (HAHA) levels [ Time Frame: 120 weeks ]
Not Provided
Not Provided
 
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
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
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 participants with relapsing multiple sclerosis. Participants will be randomized to receive either in Group A, ocrelizumab 600 milligram (mg) intravenously (IV) every 24 weeks plus Rabif placebo subcutaneously (SC) 3 times weekly, or, in Group B, Rebif 8.8 microgram (mcg) (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), and 44 mcg (Week 5 and thereafter) SC 3 times weekly plus ocrelizumab placebo IV 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, providing they fulfill the eligibility criteria.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
  • Drug: Ocrelizumab
    Ocrelizumab 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment dose and as single infusions of 600 mg on Day 1 for each 24-week treatment dose, thereafter) every 24 weeks.
    Other Name: RO4964913
  • Drug: Ocrelizumab Placebo
    Ocrelizumab dummy placebo iv according to schedule in ocrelizumab active group.
  • Drug: Rebif
    Rebif 8.8 mcg (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), 44 mcg (Week 5 and thereafter) SC injection 3 times per week.
    Other Name: Interferon beta-1a
  • Drug: Rebif placebo
    Rebif dummy placebo SC according to schedule in Rebif active group.
  • Experimental: Ocrelizumab
    Ocrelizumab 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment dose and as single infusions of 600 mg on Day 1 for each 24-week treatment dose, thereafter) every 24 weeks. Placebo injections matching Rebif SC three times per week. Planned duration of double-blind treatment is 96 weeks.
    Interventions:
    • Drug: Ocrelizumab
    • Drug: Rebif placebo
  • Active Comparator: Rebif
    Rebif 8.8 mcg (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), 44 mcg (Week 5 and thereafter) SC injection 3 times per week. Placebo infusions matching ocrelizumab infusions every 24 weeks. Planned duration of double-blind treatment is 96 weeks.
    Interventions:
    • Drug: Ocrelizumab Placebo
    • Drug: Rebif
Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators.. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
835
January 2020
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 greater than or equal to (>/=) 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 score less than or equal to (</=) 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 (for example, hepatitis B or C, Human Immunodeficiency Virus [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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belarus,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czech Republic,   France,   Germany,   Ireland,   Italy,   Mexico,   Norway,   Poland,   Russian Federation,   Slovakia,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom
Morocco
 
NCT01412333
WA21093
2010-020315-36 ( EudraCT Number )
Not Provided
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2016

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