Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. 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 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months.

NCT Number	NCT05285891
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID) Collaborators: Autoimmunity Centers of Excellence, Rho Federal Systems Division, Inc., Genentech, Inc.
Conditions	Multiple Sclerosis
Enrollment	123 participants
Start Date	2023-02-07
Primary Completion	2030-05-01 (estimated)
Study Completion	2030-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-10