The primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ) by evaluating relapse rate, progression on MRI and disability progression.
This is a multicenter, prospective, open-label, Phase IV clinical trial. Patients with relapsing forms of Multiple Sclerosis (MS), ages 18 to 65, who have received a stable dose of NTZ for 12 or more consecutive months, and have been free of relapses, disability worsening or Magnetic Resonance Imaging (MRI) progression 6 months prior to the transition screening visit will be eligible for the study. After informed consent to participate has been obtained, the patient will have physical exam (PE), non-blinded Expanded Disability Status Scale (EDSS), MRI, Multiple Sclerosis Impact Scale (MSIS-29) and labs done for the screening visit to determine eligibility. Brain MRI with and without contrast will be performed with the standard MS protocol. MRIs will be performed with 3mm slice thickness with no gaps between slices. Patients will receive their first dose of OCR 4 to 6 weeks after the last dose of NTZ. Other baseline measures, including physical exam, EDSS, MSIS-29, and labs will be performed within 4 weeks of screening. Physical exam, non-blinded EDSS, and labs will be performed at month 3, month 6, month 9, and month 12. MSIS-29 will be performed at months 6 and 12. In addition, MRIs will be performed at months 3, 6, and 12.
Study Type
OBSERVATIONAL
Enrollment
43
RWJBarnabas Health
Livingston, New Jersey, United States
Providence MS Center
Portland, Oregon, United States
Kadlec Neuroscience Center
Richland, Washington, United States
Multiple Sclerosis Center, Swedish Neuroscience Institute
Seattle, Washington, United States
Relapse Free Survival at Month 12
The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
Time frame: 12 Months
Relapse Rate at Months 3, 6, and 9
Proportion of relapse-free patients at months 3, 6, and 9
Time frame: 3, 6, and 9 months
MRI Evidence of MS Disease Activity at Months 3, 6, and 12
Proportion of patients free from MRI evidence of MS disease activity at months 3, 6, and 12
Time frame: 3, 6, and 12 Months
New or Enlarging T2 Lesions at 3, 6, and 12 Months
Proportion of patients with New or Enlarging T2 lesions at 3, 6, and 12 months. For patients with New or Enlarging T2 lesions, number of New and Enlarging T2 lesions.
Time frame: 3, 6, and 12 months
New Gd+ Lesions Detected at Months 3, 6, and 12
Proportion of patients with New Gd+ lesions detected at months 3, 6, and 12. For patients with New Gd+ lesions, number of New Gd+ lesions
Time frame: 3, 6, and 12 months
Change in the EDSS Score From Baseline to Month 12
Average change in EDSS score. The Expanded Disability Status Scale (EDSS) is an assessment used by neurologist to assess changes in the level of disability over time in patients with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scores are also based on measures of impairment in the 8 functional systems. Higher scores indicate greater impact of MS on QoL.
Time frame: 12 months
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Providence Multiple Sclerosis Center
Spokane, Washington, United States
Change in MSIS-29 From Baseline to Months 6 and 12
Average change in MSIS-29: Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Scores from individual items are summed to a total score. Physical impact score ranges from 20-80 and psychological impact scores ranges from 9-36. Higher scores indicate greater impact of MS on QoL.
Time frame: 6 and 12 months
Proportion of Patients That Discontinued OCR
Proportion of patients that stop treatment with OCR for any reason
Time frame: 12 months