Actively Recruiting
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-16
123
Participants Needed
12
Research Sites
407 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
A
Autoimmunity Centers of Excellence
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have at least one clinical episode meeting McDonald 2017 criteria for early Multiple Sclerosis with evidence of disease spread over time
- Disease duration from first symptom is 3 years or less at informed consent
- For women of childbearing potential: agree to remain abstinent or use effective contraception during treatment and for 6 months after last dose
- Women of childbearing potential are postmenarcheal, not menopausal, and not surgically sterilized
- Acceptable contraceptive methods include tubal ligation, male sterilization, hormonal contraceptives, hormone-releasing or copper intrauterine devices
- Periodic abstinence and withdrawal are not accepted contraception methods
- Barrier methods must be combined with spermicide
You will not qualify if you...
- Unable or unwilling to give informed consent or follow study protocol
- History of primary progressive, progressive relapsing, or secondary progressive multiple sclerosis
- Presence of metal or electronic devices in the body preventing MRI
- History of other neurological disorders such as cerebrovascular diseases, CNS tumors, metabolic or infectious myelopathy, inherited CNS disorders, CNS sarcoidosis, or autoimmune diseases affecting neurological function
- Pregnancy or breastfeeding; women of childbearing potential must have negative pregnancy test at screening
- Conditions requiring chronic corticosteroids or immunosuppressants
- No peripheral venous access
- History of severe allergic reactions to monoclonal antibodies
- Significant uncontrolled diseases (cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, or others)
- NYHA Class III or higher heart failure
- Active bacterial, viral, fungal, or mycobacterial infections or recent severe infections requiring hospitalization or IV antibiotics
- Active or chronic HIV, syphilis, or tuberculosis infections
- Evidence of past or untreated hepatitis B or untreated hepatitis C infection
- Active malignancy or monitoring for recurrence, except certain treated skin or cervical cancers
- Substance use disorder within past year with significant impairment
- Recent live or live-attenuated vaccines within 4 weeks before first infusion
- Contraindications or intolerance to oral or IV corticosteroids
- Prior treatment with specific MS disease-modifying therapies including fingolimod, cladribine, natalizumab, anti-CD20 molecules, alemtuzumab, chemotherapy
- Treatment with fumarates within 30 days before first infusion and related assessments
- Current or prior experimental immunomodulatory therapies without approval
- Systemic corticosteroid therapy within 4 weeks before screening samples, MRI, or first infusion
- Laboratory abnormalities including positive infection screenings, low immunoglobulin G, impaired kidney function, elevated liver enzymes, low blood counts
- Any other medical problems that may increase risk, affect compliance, or impact data quality as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
6
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10007
Actively Recruiting
7
University of Rochester Medical Center
Rochester, New York, United States, 14627
Actively Recruiting
8
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
The University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, United States, 77030
Actively Recruiting
12
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
A
Amit Bar-Or
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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