A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- 23-PPV
- 13-PCV Booster
- Influenza Vaccine
- KLH
- OCR
- TT Vaccine
Results by group
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
8 weeks after TT vaccine
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Group A (A1 + A2) | 23.9 percentage of participants | 68 | |
| Group B | 54.5 percentage of participants | 34 |
Group A (A1 + A2)
Group B
normal distribution approximation -30.7 (95% CI -50.5–-10.8)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Group A1 | 33 | 5 (15.2%) | 0 |
| Group A2 | 35 | 5 (14.3%) | 0 |
| Group B | 34 | 6 (17.6%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
8 weeks after TT vaccine
Immune response
Other measures (31)
Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
4 weeks after TT vaccine
Immune responsePercentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
4 weeks after TT vaccine
Immune responseMean Levels of Anti-Tetanus Antibody
Immediately prior to and at 4 and 8 weeks after TT vaccine
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Mean Levels of Anti-KLH Antibody: Ig M
Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
4 weeks after 23-PPV
Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes
4 weeks after 23-PPV
Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes
4 weeks after 23-PPV
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to and 4 weeks after 23-PPV
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* Diagnosis of RMS in accordance with the revised McDonald criteria * Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap) * Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive * For sexually active female participants of reproductive potential, use of reliable means of contraception
Exclusion criteria
* Contraindications for or intolerance to oral or IV corticosteroids, including IV 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Oct 2015
Main results due
Feb 2017
Finished
Sept 2021
Results posted
Jun 2018