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NCT02792231 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 955
- Enrollment target
NCT02792231: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02792231 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 955 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02792231, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 955 participants
- Enrollment target
Study Summary
To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis
Primary Outcome
ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes
Interventions
- DRUG Ofatumumab subcutaneous injection
- DRUG Teriflunomide-matching placebo capsules
- DRUG Teriflunomide capsule
- DRUG Matching placebo of ofatumumab subcutaneous injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 955 participants |
| Start Date | 2016-08-26 |
| Est. Completion | 2020-10-22 |
| Phase | Phase 3 |
What the finished NCT02792231 record still lists
NCT02792231 is an interventional study that assigns participants to a tested intervention. The registered 955 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 4 interventions - of which Ofatumumab subcutaneous injection is the first listed.
NCT02792231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02792231 about?
NCT02792231 is a clinical study titled "Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.". To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis
What is the current status of trial NCT02792231?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 955 participants. The study started on 2016-08-26. Estimated completion is 2020-10-22.
What interventions are being tested in trial NCT02792231?
The interventions under investigation include: Ofatumumab subcutaneous injection (DRUG), Teriflunomide-matching placebo capsules (DRUG), Teriflunomide capsule (DRUG), Matching placebo of ofatumumab subcutaneous injections (DRUG).
Who is sponsoring clinical trial NCT02792231?
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 NCT02792231's enrollment target sits among peer trials
955 333rd of 2000 higher than 1,668 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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