Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)
National Institute of Allergy and Infectious Diseases (NIAID)
123 participants
Jan 12, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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 infusions every 6 months from Month 30 through Month 48.
Locations(12)
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NCT05285891