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NCT01247324 · ClinicalTrials.gov registry record · Phase 3
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 821
- Enrollment target
NCT01247324: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01247324 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 821 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01247324, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 821 participants
- Enrollment target
Study Summary
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.
Primary Outcome
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
Interventions
- DRUG Ocrelizumab
- DRUG Interferon beta-1a
- DRUG Ocrelizumab-matching placebo
- DRUG Interferon beta-1a-matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 821 participants |
| Start Date | 2011-08-31 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 3 |
What the finished NCT01247324 record still lists
NCT01247324 is an interventional study that assigns participants to a tested intervention. The registered 821 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Ocrelizumab is the first listed.
NCT01247324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01247324 about?
NCT01247324 is a clinical study titled "A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis". This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching pla...
What is the current status of trial NCT01247324?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 821 participants. The study started on 2011-08-31. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT01247324?
The interventions under investigation include: Ocrelizumab (DRUG), Interferon beta-1a (DRUG), Ocrelizumab-matching placebo (DRUG), Interferon beta-1a-matching placebo (DRUG).
Who is sponsoring clinical trial NCT01247324?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01247324's enrollment target sits among peer trials
821 404th of 2000 higher than 1,597 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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