RecruitingPhase 4NCT05285891

Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

123 participants

Start Date

Jan 12, 2023

Study Type

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether people with early relapsing multiple sclerosis (MS) can safely stop or reduce their treatment with ocrelizumab — an infusion given every 6 months — after achieving stable disease. MS medications carry long-term risks, so understanding whether treatment can be safely paused is important for patients. **You may be eligible if...** - You have been diagnosed with multiple sclerosis meeting the McDonald 2017 criteria - Your disease has not progressed for a period of time (specific disease duration criteria apply) - You are a woman of childbearing potential and willing to use effective contraception during the study and for 6 months after the last dose **You may NOT be eligible if...** - Your disease has been present for more than 3 years since first symptom (at time of consent) - You have an active infection or significant other medical condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGOcrelizumab

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.

DRUGPlacebo for Ocrelizumab

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


Locations(12)

Yale School of Medicine

New Haven, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas Health Science Center at Houston, McGovern Medical School

Houston, Texas, United States

Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05285891


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