Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

NCT05285891 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

Multiple Sclerosis

Interventions

DRUG

Ocrelizumab

Two 300 mg intravenous (IV) OCR infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg OCR infusions every 6 months from Month 6 through Month 48.

DRUG

Placebo for Ocrelizumab

Placebo infusions every 6 months from Month 30 through Month 48.

Sponsors & Collaborators

Autoimmunity Centers of Excellence (ACE)
collaborator UNKNOWN
Rho Federal Systems Division, Inc.
collaborator INDUSTRY
Genentech, Inc.
collaborator INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH

Principal Investigators

Amit Bar-Or, M.D. · University of Pennsylvania, Perelman School of Medicine: Department of Neurology

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: TRIPLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 55 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2023-01-12
Primary Completion: 2030-05-01
Completion: 2030-11-01
FDA Drug: Yes

Countries

United States

Study Locations

More Related Trials

Entities

Diseases

Multiple Sclerosis