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NCT05285891 · ClinicalTrials.gov registry record · Phase 4
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
A Phase 4 study of Multiple Sclerosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 4
- Development phase
- 123
- Enrollment target
- 12
- Study locations
NCT05285891 is a Phase 4 study of Multiple Sclerosis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 123 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (79% lower). The trial reports 12 study locations across 9 states.
The verdict
NCT05285891, a Phase 4 study of Multiple Sclerosis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 123 participants
- Enrollment target
- 12
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (79% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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.
NCT05285891 reports 12 study locations spanning 9 distinct geographic areas - top geographies include Massachusetts, New York, Texas.
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.
What interventions are being tested in trial NCT05285891?
The interventions under investigation include: Ocrelizumab (DRUG), Placebo for Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT05285891?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.