drugset / Trial / NCT02545868

A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

NCT02545868

Phase 3 Completed 102 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelSupportive care

Summary

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza vaccine, keyhole limpet hemocyanin \[KLH\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

Timeline

Start
2015-10-27
Primary completion
2017-02-14
Completion
2021-09-21

Drugs

EvaluationDrugModalityDoseRoute
Subject 13-PCV Booster Vaccine Intramuscular
Subject 23-PPV Vaccine 0.5 ml Intramuscular
Subject Influenza Virus Vaccine Vaccine Intramuscular
Subject Ocrelizumab Monoclonal antibody 600 mg Intravenous
Subject TT Vaccine Vaccine 0.5 ml Intramuscular
Subject keyhole limpet hemocyanin Vaccine 1 mg Subcutaneous