This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
735
Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.
Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit \>=12 weeks (\>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of \>= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is \<=5.5 points (inclusive), or an increase of \>=0.5 points, if baseline EDSS is \>5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Time frame: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit \>=12 weeks (\>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of \>= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is \<=5.5 points (inclusive), or an increase of \>=0.5 points, if baseline EDSS is \>5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Time frame: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120
Time frame: Baseline, Week 120
Percent Change From Baseline in Total Volume of T2 Lesions at Week 120
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States
Barrow Neurology Clinic
Phoenix, Arizona, United States
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States
Arizona Neuroscience Research LLC
Phoenix, Arkansas, United States
Sutter East Bay Medical Foundation
Berkeley, California, United States
MS Center of Southern California
Newport Beach, California, United States
Univ of CA Davis Med Ctr; Neurology
Sacramento, California, United States
Univ of CA San Francisco; Department of Neurology
San Francisco, California, United States
University of Colorado; Anschutz Medical Campus Department of Neurology
Aurora, Colorado, United States
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
Miami, Florida, United States
...and 174 more locations
Time frame: From Baseline to Week 120
Percent Change in Total Brain Volume From Week 24 to Week 120
Time frame: From Week 24 to Week 120
Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120
The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0-100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: From Baseline to Week 120
Number of Participants With at Least One Adverse Event (AE)
AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.
Time frame: From baseline to 9 years