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Active, not recruiting Phase 4 Interventional

Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

ClinicalTrials.gov ID: NCT05285891

Public ClinicalTrials.gov record NCT05285891. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05285891
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Enrollment
123 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 6, 2023
Primary completion
Aug 24, 2031
Completion
Feb 24, 2032
Last update posted
Aug 31, 2026

2023 – 2032

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
Yale School of Medicine New Haven Connecticut 06510
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007
Northwestern University Chicago Illinois 60611
Massachusetts General Hospital Boston Massachusetts 02114
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01655
RWJ Barnabas Health Livingston New Jersey 07039
Icahn School of Medicine at Mount Sinai New York New York 10007
University of Rochester Medical Center Rochester New York 14627
Oklahoma Medical Research Foundation Oklahoma City Oklahoma 73104
University of Pennsylvania, Perelman School of Medicine Philadelphia Pennsylvania 19104
University of Texas Southwestern Medical Center Dallas Texas 75390
The University of Texas Health Science Center at Houston, McGovern Medical School Houston Texas 77030
Virginia Commonwealth University School of Medicine Richmond Virginia 23298

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05285891, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 31, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05285891 live on ClinicalTrials.gov.

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