Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

Conditions

• Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Ocrelizumab — DRUG
  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.
• Placebo for Ocrelizumab — DRUG
  Placebo infusions every 6 months from Month 30 through Month 48.

Study Details

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.

Key Dates

Start date

Jan 12, 2023

Status verified

Apr 2026

Primary completion

May 1, 2030

Completion

Nov 1, 2030

Study Design

Enrollment

123 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ocrelizumab Arm
  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. In this arm participants will continue to receive OCR infusions every 6 months through Month 48.
• Placebo Comparator: Placebo Arm
  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. In this arm, starting at Month 30, participants will receive placebo infusions every 6 months through Month 48.

Primary Outcome Measure

Absence of clinical relapse [ Time Frame: From Month 24 to Month 48 ]

Central Contacts

• Amit Bar-Or
  (215) 316-5151

Locations (12)

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