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NCT02283853 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
NCT02283853: Completed Phase 3 study, sponsored by Biogen.
NCT02283853 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02283853, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
Study Summary
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in participants who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in participants who completed Week 96 in Part 1 of Study 109MS306.
Primary Outcome
Participants who were free of new or newly enlarging T2 hyperintense lesions were assessed on Brain MRI scans.
Interventions
- DRUG dimethyl fumarate
- DRUG Interferon β-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2014-08-28 |
| Est. Completion | 2025-07-08 |
| Phase | Phase 3 |
What the finished NCT02283853 record still lists
NCT02283853 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which dimethyl fumarate is the first listed.
NCT02283853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02283853 about?
NCT02283853 is a clinical study titled "Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)". The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate th...
What is the current status of trial NCT02283853?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2014-08-28. Estimated completion is 2025-07-08.
What interventions are being tested in trial NCT02283853?
The interventions under investigation include: dimethyl fumarate (DRUG), Interferon β-1a (DRUG).
Who is sponsoring clinical trial NCT02283853?
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 NCT02283853's enrollment target sits among peer trials
156 1506th of 2000 higher than 492 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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