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A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

NCT01194570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 735

Last updated 2024-01-10

Study results available
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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.

Conditions

  • Multiple Sclerosis, Primary Progressive

Interventions

DRUG

Ocrelizumab

Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.

OTHER

Placebo

Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-02
Primary Completion
2015-07-23
Completion
2022-12-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Peru
  • Poland
  • Portugal
  • Romania
  • Russia
  • Spain
  • Switzerland
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01194570 on ClinicalTrials.gov