A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT01194570
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2023-05-22
Brief 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. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.
OFFICIAL TITLE
A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
INTERVENTION / TREATMENT
Drug: Ocrelizumab
Other: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2011-03-02 |
| Primary Completion (Actual) | 2015-07-23 |
| Study Completion (Actual) | 2022-12-31 |
| Enrollment (Actual) | 735 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | WA25046 2010-020338-25 (EudraCT Number) |