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NCT05123703 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
A Phase 3 study of Relapsing Remitting Multiple Sclerosis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
- 20
- Study locations
NCT05123703: Active Phase 3 study of Relapsing Remitting Multiple Sclerosis, sponsored by Hoffmann-La Roche.
NCT05123703 is a Phase 3 study of Relapsing Remitting Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 188 participants, roughly in line with the 195-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05123703, a Phase 3 study of Relapsing Remitting Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
- 20
- Study locations
Study Summary
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.
Primary Outcome
The population-level summary is rate ratio of ARR. The ARR is calculated as the total number of protocol-defined relapses divided by the total patient-years. Protocol-defined relapse is the occurrence of new/worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by relatively stable or improving neurological state for ≥ 30 days. Symptoms must persist for \>24 hours \& should not be attributable to confounding clinical factors. The new/worsening neurologi
Conditions Studied
Interventions
- DRUG Fingolimod
- DRUG Ocrelizumab
- OTHER Ocrelizumab Placebo
- OTHER Fingolimod Placebo
Study Locations (20)
Other
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan - Ciudad de Buenos Aires
- Clinica Universitaria Reina Fabiola - Córdoba
- Centro de Investigaciones Médicas Tucuman - San Miguel de Tucumán
- Medizinische Universität Wien - Vienna
- Hôpital Universitaire des Enfants Reine Fabiola - Brussels
- Cliniques Universitaires St-Luc - Brussels
California
- UC San Diego - La Jolla
- University of California San Francisco - San Francisco
Ohio
- Cleveland Clinic, Mellen Center for Multiple Sclerosis - Cleveland
- The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company - Columbus
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Hospital - Washington D.C.
Maryland
- Johns Hopkins Medicine - Baltimore
Massachusetts
- Boston Children's Hospital Central Pharmacy - Boston
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2029-09-17 |
| Phase | Phase 3 |
What the registry record for NCT05123703 still lists
NCT05123703 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 195-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target.
The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 4 interventions - of which Fingolimod is the first listed.
NCT05123703 names 20 study sites across 13 states, led by Other, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05123703 about?
NCT05123703 is a clinical study titled "A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)". This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has comple...
What is the current status of trial NCT05123703?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2022-05-19. Estimated completion is 2029-09-17.
What conditions does trial NCT05123703 study?
This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.
What interventions are being tested in trial NCT05123703?
The interventions under investigation include: Fingolimod (DRUG), Ocrelizumab (DRUG), Ocrelizumab Placebo (OTHER), Fingolimod Placebo (OTHER).
Who is sponsoring clinical trial NCT05123703?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05123703 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsing Remitting 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 NCT05123703's enrollment target sits among peer trials
188 6th of 25 higher than 20 of 25 other Relapsing Remitting Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing Remitting 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.
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