drugset / Trial / NCT02545868
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |