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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05269004
The ClinicalTrials.gov registry entry for NCT05269004 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 581-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (124% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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