Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
Status:
Not yet recruiting
Trial end date:
2028-04-30
Target enrollment:
Participant gender:
Summary
This study is a study of ocrelizumab (OCR) treatment-discontinuation in patients with early
Relapsing Remitting Multiple Sclerosis (RRMS). All eligible participants will be initiated on
OCR using the standard approved administration schedule of two 300 mg infusions separated by
14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at month 6
and month 12. At month 12, participants will be randomized (1:1:1) to one of three Arms: Arm
1: placebo infusions every 6 months; Arm 2: OCR infusions at months 18 and 24 and then after
month 24 switch to placebo infusions every 6 months; Arm 3: OCR infusions every 6 months. The
treatment period will be for a total of 48 months.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)