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NCT04544436 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
A Phase 3 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 864
- Enrollment target
- 20
- Study locations
NCT04544436: Active Phase 3 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
NCT04544436 is a Phase 3 study of Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 864 participants, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (48% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04544436, a Phase 3 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 864 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
Primary Outcome
Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of the 3 criteria: 1) CDP=12-week confirmed increase (CI) from baseline (FB) in expanded disability status scale (EDSS) score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of \>5.5 OR 2) 12-week CI of ≥20% FB in Timed 25-foot Walk Test (T25FWT) score OR 3)12-week CI of ≥ 20% FB in 9-hole Peg Test (9-HPT) score. EDSS = disabilit
Conditions Studied
Interventions
- DRUG Methylprednisolone
- DRUG Ocrelizumab
- DRUG Antihistamine
Study Locations (20)
Alabama
- North Central Neurology Associates - Cullman
- Alabama Neurology Associates - Homewood
California
- Profound Research, LLC - Carlsbad
- Stanford University Medical Center - Stanford
Florida
- Neurology Associates, PA - Maitland
- University of South Florida - Tampa
Arizona
- 21st Century Neurology - Phoenix
Colorado
- Advanced Neurology of Colorado, LLC - Fort Collins
Indiana
- American Health Network Institute, LLC - Avon
Kansas
- University of Kansas Medical Center - Kansas City
Louisiana
- The NeuroMedical Clinic of Central Louisiana - Alexandria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 864 participants |
| Start Date | 2020-11-26 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 3 |
What the registry record for NCT04544436 still lists
NCT04544436 is an interventional study that assigns participants to a tested intervention. The registered 864 participants enrollment target is mid-sized for trials with a published cap, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (48% higher).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Methylprednisolone is the first listed.
NCT04544436 names 20 study sites across 17 states, led by Alabama, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04544436 about?
NCT04544436 is a clinical study titled "A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)". This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
What is the current status of trial NCT04544436?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 864 participants. The study started on 2020-11-26. Estimated completion is 2028-08-31.
What conditions does trial NCT04544436 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04544436?
The interventions under investigation include: Methylprednisolone (DRUG), Ocrelizumab (DRUG), Antihistamine (DRUG).
Who is sponsoring clinical trial NCT04544436?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04544436 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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 NCT04544436's enrollment target sits among peer trials
864 34th of 315 higher than 282 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
-
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
RECRUITING · Phase 3
-
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
RECRUITING · Phase 3
-
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
ACTIVE NOT RECRUITING · Phase 3
-
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 3
-
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 3
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