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NCT01633112 · ClinicalTrials.gov registry record · Phase 3
MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,064
- Enrollment target
NCT01633112: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01633112 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 1,064 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01633112, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,064 participants
- Enrollment target
Study Summary
The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS
Primary Outcome
Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.
Interventions
- DRUG fingolimod
- DRUG glatiramer acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,064 participants |
| Start Date | 2012-08-09 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 3 |
Why NCT01633112 stopped before completion
NCT01633112 is an interventional study that assigns participants to a tested intervention. Its 1,064 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which fingolimod is the first listed.
NCT01633112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01633112 about?
NCT01633112 is a clinical study titled "MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone". The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS
What is the current status of trial NCT01633112?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,064 participants. The study started on 2012-08-09. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT01633112?
The interventions under investigation include: fingolimod (DRUG), glatiramer acetate (DRUG).
Who is sponsoring clinical trial NCT01633112?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01633112's enrollment target sits among peer trials
1,064 274th of 2000 higher than 1,727 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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