Clinical Trial: A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to a
Brief Summary: This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.
Detailed Summary:
Sponsor: Genentech, Inc.
Current Primary Outcome: Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period [ Time Frame: Baseline up to Week 96 ]
Original Primary Outcome: Percentage of participants Without Any Protocol-defined Events During 96-week Period [ Time Frame: 96 weeks ]
Current Secondary Outcome:
- Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period [ Time Frame: Baseline up to Weeks 24 and 48 ]Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
- Time to Protocol-Defined Event [ Time Frame: Baseline up to Week 96 ]Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
- Percentage of Participants With Protocol-Defined Relapse Per Year [ Time Frame: Baseline up to Week 96 ]Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.
- Time to Onset of First Protocol-Defined Relapse [ Time Frame: Baseline up to Week 96 ]Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.
- Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI [ Time Frame: Baseline up to Week 96 ]
- Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI [ Time Frame: Baseline up to Week 96 ]
- Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score [ Time Frame: Baseline up to Week 96 ]
- Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ]
- Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI [ Time Frame: Baseline, Weeks 24, 48, and 96 ]
- Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ]
- Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 144 weeks ]
Original Secondary Outcome:
- Percentage of participants Without Any Protocol-defined Events During 24-week Period and 48-week Period [ Time Frame: 24 weeks and 48 weeks ]
- Time to Protocol-defined Event [ Time Frame: 96 weeks ]
- Annualized Protocol-defined Relapse Rate at Week 96 [ Time Frame: Week 96 ]
- Time to Onset of First Relapse [ Time Frame: 96 weeks ]
- Time to Onset of First T1 Gadolinium-enhanced (Gd-enhanced) Lesion [ Time Frame: 96 weeks ]
- Time to Onset of First New and/or Enlarging T2 Lesion [ Time Frame: 96 weeks ]
- Time to Onset of Confirmed Disability Progression for at least 24 Weeks [ Time Frame: 96 weeks ]
- Total Number of T1 Gadolinium-enhancing (Gd-enhancing) Lesions as Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Weeks 24, 48, and 96 ]
- Change From Baseline in Total T2 Lesion Volume Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ]
- Total Number of New and/or Enlarging T2 Lesions Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Weeks 24, 48, and 96 ]
Information By: Genentech, Inc.
Dates:
Date Received: December 18, 2015
Date Started: February 11, 2016
Date Completion: December 31, 2019
Last Updated: May 8, 2017
Last Verified: May 2017