A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Ocrelizumab in Patients With Radiologically Isolated Syndrome
Overview
- Phase
- Phase 4
- Intervention
- Ocrelizumab
- Conditions
- Radiologically Isolated Syndrome
- Sponsor
- Yale University
- Enrollment
- 3
- Locations
- 4
- Primary Endpoint
- Time to Development of First New Radiologic or Clinical Evidence of MS
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 4 study in which eligible patients with RADIOLOGICALLY ISOLATED SYNDROME (RIS) (as defined by meeting 2017 McDonald criteria for DIS) will be randomized 1:1 to receive ocrelizumab treatment or placebo (standard of care).
Detailed Description
This study is designed to investigate the treatment effect of ocrelizumab compared with placebo on clinical and radiological outcomes in patients with RIS (i.e., asymptomatic CNS lesions fulfilling the 2017 McDonald criteria for DIS), as well as neuroimaging, serologic, immunologic and other exploratory biomarkers of MS disease biology in order to improve the understanding of B cell biology in early disease pathophysiology, characterize the emergence of CNS autoimmunity, and the mechanism of action of ocrelizumab in this population.
Investigators
Erin E Longbrake
Assistant Professor of Neurology
Yale University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ocrelizumab
Three courses of ocrelizumab will be administered over the course of the study.
Intervention: Ocrelizumab
Placebo
Three courses of placebo will be administered over the course of the study.
Intervention: Placebo
Outcomes
Primary Outcomes
Time to Development of First New Radiologic or Clinical Evidence of MS
Time Frame: Up 4 years
The primary efficacy endpoint for this study is to evaluate the efficacy of ocrelizumab compared with placebo on delaying the time to development of new radiological or clinical evidence of MS, defined as the time from baseline to first new T1 gadolinium-enhancing lesions and/or new or enlarging T2 lesions consistent with MS in participants OR first clinical evidence of MS, i.e., neurological event resulting from CNS demyelination as evidenced by acute or progressive clinical syndrome consistent with MS in participants.
Secondary Outcomes
- Cumulative Number of New or Enlarging T2 Lesions(Up to 4 years)
- Change in T2-lesion Volume(Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeks)
- Cumulative Number of New T1 Gadolinium-enhancing Lesions(Up to 4 years)
- Change in Total Brain Volume(Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeks)
- Change in Total Spinal Cord Volume(Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeks)
- Change in Serum NfL (sNfL)(Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 130 weeks, 156 weeks, 182 weeks, 208 weeks)