Trial record 2 of 20 for:    ocrelizumab

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: July 14, 2016
Last verified: July 2016
  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 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.

Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: Ocrelizumab
Drug: Ocrelizumab Placebo
Drug: Rebif
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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Annualized Protocol-defined Relapse Rate at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 96 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab [ Time Frame: Baseline up to Week 96 ] [ Designated as safety issue: Yes ]
  • Time to Onset of Confirmed Disability Progression for at least 12 Weeks as Assessed by Expanded Disability Status Scale (EDSS) Score [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Total Number of T1 Gadolinium Enhanced Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Total Number of T2 Hyperintense Lesion as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Confirmed Disability Improvement for at Least 12 Weeks as Assessed by EDSS Score [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Time to Onset of Confirmed Disability Progression for at Least 24 Weeks as Assessed by EDSS Score [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Total Number of New T1-Hypointense Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Change From Baseline in Multiple Sclerosis Functional Composite Scale (MSFCS) Score at Week 96 [ Time Frame: Baseline, Week 96 ] [ Designated as safety issue: No ]
  • Percentage Change in Brain Volume as Detected by Brain MRI From Week 24 to Week 96 [ Time Frame: Week 24, Week 96 ] [ Designated as safety issue: No ]
  • Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) Score at Week 96 [ Time Frame: Baseline, Week 96 ] [ Designated as safety issue: No ]
  • Percentage of Participants With no Evidence of Disease Activity (NEDA) at Week 96 as Assessed by Neurological Symptoms and MRI [ Time Frame: Week 96 ] [ Designated as safety issue: No ]

Enrollment: 835
Study Start Date: September 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Rebif placebo
Rebif dummy placebo SC according to schedule in Rebif active group.
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.
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412333

  Show 215 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01412333     History of Changes
Other Study ID Numbers: WA21093  2010-020315-36 
Study First Received: August 8, 2011
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple 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
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 24, 2016