NCT05285891 · National Institute of Allergy and Infectious Diseases (NIAID)
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
(AMS05)
What this study is about
This study is a forward-looking, multi-center, randomly assigned, double blinded, compared against an inactive treatment 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.
View original scientific description
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.
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.
Primary outcome measures
Absence of clinical relapse
Time frame: From Month 24 to Month 48
Durable remission of relapsing disease activity. This is defined as the absence of new relapsing disease activity from Month 24 through Month 48. This includes absence of clinical relapse as well as absence of evidence of MS disease activity by MRI defined by new or enlarging T2 lesions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have at least one clinical episode that satisfies McDonald 2017 criteria for early Multiple sclerosis (MS) for up to 2 years post-event with a dissemination in time that can be met clinically, by Magnetic Resonance Imaging (MRI), or based on oligoclonal band (OCB) positivity 2. Have a length of disease duration, from first symptom, of ≤ 2 years 3. For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use effective methods of contraception during the treatment period and for at least 6 months after the last dose of study drug: 1. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus) 2. Examples of contraceptive methods include bilateral tubal ligation, male sterilization, est
Where
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Chicago, Illinois
- Boston, Massachusetts
- Worcester, Massachusetts
- Livingston, New Jersey
- New York, New York
- Rochester, New York
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- Dallas, Texas
- Houston, Texas
And 1 more location — see the full list below.
Collaborators
Autoimmunity Centers of Excellence, Rho Federal Systems Division, Inc., Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations