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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: Recruiting Phase 4 study of Multiple Sclerosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT05285891 shows while recruiting
NCT05285891 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (79% lower).
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 lists 12 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05285891's enrollment target sits among peer trials
123 108th of 315 higher than 208 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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