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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 821 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01247324
The ClinicalTrials.gov registry entry for NCT01247324 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 821 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ocrelizumab is the first listed.
NCT01247324 reports 0 study locations.
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.
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