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NCT04926818 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, MS, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT04926818: Active Phase 3 study of Multiple Sclerosis, MS, sponsored by Novartis Pharmaceuticals.
NCT04926818 is a Phase 3 study of Multiple Sclerosis, MS that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 129 participants, above the 49-participant average among 7 other Multiple Sclerosis, MS trials with a reported enrollment target (163% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04926818, a Phase 3 study of Multiple Sclerosis, MS, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
Study Summary
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Primary Outcome
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
Conditions Studied
Interventions
- DRUG Fingolimod
- DRUG Siponimod
- DRUG Ofatumumab
- OTHER Fingolimod placebo
- OTHER Siponimod placebo
Study Locations (20)
Other
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Esneux
- Novartis Investigative Site - Ghent
- Novartis Investigative Site - Zagreb
- Novartis Investigative Site - Tallinn
- Novartis Investigative Site - Le Kremlin-Bicêtre
Quebec
- Novartis Investigative Site - Montreal
- Novartis Investigative Site - Montreal
Arkansas
- Arkansas Childrens Hosp Rsch Inst - Little Rock
California
- Childrens Hospital Los Angeles - Los Angeles
District of Columbia
- Childrens National Medical Center - Washington D.C.
Florida
- Axiom Clinical Research of Florida - Tampa
Pennsylvania
- Childrens Hospital of Philadelphia - Philadelphia
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2031-03-06 |
| Phase | Phase 3 |
What the registry record for NCT04926818 still lists
NCT04926818 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 49-participant average among 7 other Multiple Sclerosis, MS trials with a reported enrollment target (163% higher).
The record links to 1 condition, with Multiple Sclerosis, MS appearing as the primary indexed condition, and to 5 interventions - of which Fingolimod is the first listed.
NCT04926818 names 20 study sites across 13 states, led by Other, Quebec, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04926818 about?
NCT04926818 is a clinical study titled "Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis". Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
What is the current status of trial NCT04926818?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2021-10-05. Estimated completion is 2031-03-06.
What conditions does trial NCT04926818 study?
This clinical trial studies the following conditions: Multiple Sclerosis, MS.
What interventions are being tested in trial NCT04926818?
The interventions under investigation include: Fingolimod (DRUG), Siponimod (DRUG), Ofatumumab (DRUG), Fingolimod placebo (OTHER), Siponimod placebo (OTHER).
Who is sponsoring clinical trial NCT04926818?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04926818 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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