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NCT05269004 · ClinicalTrials.gov registry record · Phase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 1,300
- Enrollment target
- 20
- Study locations
NCT05269004: Active Phase 3 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
NCT05269004 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 1,300 participants, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (124% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269004, 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
- 1,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
Conditions Studied
Interventions
- DRUG Ocrelizumab
Study Locations (20)
Florida
- Neurology Associates PA - Maitland
- University of Miami - Miami
- Neurological Services of Orlando - Orlando
- University of South Florida - Tampa
- Vero Beach Neurology and Research Institute - Vero Beach
California
- MS Center of California - Laguna Hills
- Stanford Hospital and Clinics - Palo Alto
- University of California San Francisco - San Francisco
- University of California San Francisco - San Francisco
Arizona
- Barrow Neurological Institute - Phoenix
- Arizona Neuroscience Research LLC - Phoenix
Colorado
- University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) - Aurora
- Advanced Neurosciences Research LLC - Fort Collins
Illinois
- Northwestern University - Chicago
- Consultants in Neurology Ltd - Northbrook
Georgia
- Atlanta Neuroscience Institute - Atlanta
Indiana
- Indiana Univ School of Med - Indianapolis
Kansas
- Kansas University Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,300 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What the registry record for NCT05269004 still lists
NCT05269004 is an interventional study that assigns participants to a tested intervention. Its 1,300 participants enrollment target places it among the larger protocols in the corpus, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (124% higher).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT05269004 names 20 study sites across 10 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05269004 about?
NCT05269004 is a clinical study titled "A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis". This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA2...
What is the current status of trial NCT05269004?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,300 participants. The study started on 2022-05-03. Estimated completion is 2027-12-31.
What conditions does trial NCT05269004 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT05269004?
The interventions under investigation include: Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT05269004?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05269004 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. 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 NCT05269004's enrollment target sits among peer trials
1,300 19th of 315 higher than 297 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
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Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
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Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
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Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
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