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Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
NCT05285891 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Ocrelizumab
- DRUG Placebo for Ocrelizumab
Study Locations (12)
Massachusetts
- Massachusetts General Hospital — Boston
- University of Massachusetts Memorial Medical Center — Worcester
New York
- Icahn School of Medicine at Mount Sinai — New York
- University of Rochester Medical Center — Rochester
Texas
- University of Texas Southwestern Medical Center — Dallas
- The University of Texas Health Science Center at Houston, McGovern Medical School — Houston
Connecticut
- Yale School of Medicine — New Haven
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Illinois
- Northwestern University — Chicago
Oklahoma
- Oklahoma Medical Research Foundation — Oklahoma City
Pennsylvania
- University of Pennsylvania, Perelman School of Medicine — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2030-11-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05285891
The ClinicalTrials.gov registry entry for NCT05285891 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Ocrelizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05285891 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Massachusetts, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05285891 about?
NCT05285891 is a clinical study titled "Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis". 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 ...
What is the current status of trial NCT05285891?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 123 participants. The study started on 2023-01-12. Estimated completion is 2030-11-01.
What conditions does trial NCT05285891 study?
This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05285891?
The interventions under investigation include: Ocrelizumab (DRUG), Placebo for Ocrelizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05285891?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05285891 being conducted?
This trial has 12 study locations across Connecticut, District of Columbia, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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