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

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

Outcome

Missed primary endpoint

paper Positive response rate to TT vaccine at 8 weeks was 23.9% in the OCR vs 54.5% in the control group. PMID 32727835 ↗

Publications

Bar-Or A, Calkwood JC, Chognot C, Evershed J, Fox EJ, Herman A, Manfrini M, McNamara J, Robertson DS, Stokmaier D, Wendt JK, Winthrop KL, Traboulsee A. Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study. Neurology. 2020 Oct 6;95(14):e1999-e2008. doi: 10.1212/WNL.0000000000010380. Epub 2020 Jul 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	13-PCV Booster	Vaccine	—	Intramuscular
Subject	23-PPV	Vaccine	0.5 ml	Intramuscular
Subject	Influenza 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