Clinical Trial Details

Overview

Research Study Summary

A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis

Purpose

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT], 23-valent pneumococcal polysaccharide vaccine [23-PPV], influenza vaccine, and keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

To Learn more

CW ID: 212061
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 to 55 Years
Overall Status
Recruiting
Lead Sponsor
Hoffmann-La Roche
Facility Type
Out-Patient

Eligibility

Inclusion Criteria:

  • Diagnosis of RMS in accordance with the revised McDonald criteria
  • Received at least 1 previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
  • Expanded disability status scale (EDSS) at baseline from 0 to 5.5 points, inclusive
  • For sexually active participants with reproductive potential, use of reliable means of contraception

Exclusion Criteria:

  • Contraindications for or intolerance to oral or intravenous corticosteroids, including intravenous methylprednisolone, according to the country label
  • Known presence of other neurologic disorders
  • Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis (MS)

More Info

Protocol Number: BN29739

Contact

Bradlee McCoy
University of South Florida- Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33613
Phone: 813-974-9423

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