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NCT03870763 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
NCT03870763: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT03870763 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03870763, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
Study Summary
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.
Primary Outcome
A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. Time to relapse is defined as from the first dose of the study drug to the day of relapse. Time to First Relapse is estimated by Kaplan Mayer method.
Interventions
- DRUG Placebo
- DRUG Dimethyl Fumarate
- DRUG Peginterferon Beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-03-19 |
| Est. Completion | 2022-07-21 |
| Phase | Phase 3 |
Why NCT03870763 stopped before completion
NCT03870763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03870763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03870763 about?
NCT03870763 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants". The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and ...
What is the current status of trial NCT03870763?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2019-03-19. Estimated completion is 2022-07-21.
What interventions are being tested in trial NCT03870763?
The interventions under investigation include: Placebo (DRUG), Dimethyl Fumarate (DRUG), Peginterferon Beta-1a (DRUG).
Who is sponsoring clinical trial NCT03870763?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03870763's enrollment target sits among peer trials
11 1989th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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