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NCT01194570 · ClinicalTrials.gov registry record · Phase 3
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 735
- Enrollment target
NCT01194570: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01194570 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 735 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
NCT01194570, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 735 participants
- Enrollment target
Study Summary
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.
Primary Outcome
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit \>=12 weeks (\>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of \>= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is \<=5.5 points (inclusive), or an in
Interventions
- OTHER Placebo
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 735 participants |
| Start Date | 2011-03-02 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 3 |
What the finished NCT01194570 record still lists
NCT01194570 is an interventional study that assigns participants to a tested intervention. The registered 735 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 2 interventions - of which Placebo is the first listed.
NCT01194570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01194570 about?
NCT01194570 is a clinical study titled "A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis". This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.
What is the current status of trial NCT01194570?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 735 participants. The study started on 2011-03-02. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT01194570?
The interventions under investigation include: Placebo (OTHER), Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT01194570?
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 NCT01194570's enrollment target sits among peer trials
735 481st of 2000 higher than 1,519 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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