Phase 3
Completed N=102
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Source: ClinicalTrials.gov NCT02545868 ↗
Enrolled (actual)
102
Serious AEs
15.7%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine — 23.9; 54.5 percentage of participants
◆ Published Evidence
Highly cited
338citations · ~56 / year
Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study.
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).
Linked Publications
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Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine |
23.9; 54.5 | — |
| SECONDARY Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine |
24.2; 60.6 | — |
| SECONDARY Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers |
40.9; 87.9 | — |
| SECONDARY Mean Levels of Anti-Tetanus Antibody |
1.680; 2.147; 4.132; 12.157; 3.743; 9.812 | — |
| SECONDARY Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G |
274; 235; 384; 1086; 2916; 17737 | — |
| SECONDARY Mean Levels of Anti-KLH Antibody: Ig M |
100; 130; 124; 217; 361; 1086 | — |
| SECONDARY Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV |
49.3; 100.0; 53.7; 97.1; 34.3; 82.4 | — |
| SECONDARY Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes |
86.6; 100.0 | — |
| SECONDARY Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes |
37.3; 97.1 | — |
| SECONDARY Mean Levels of Anti-Pneumococcal Antibody |
0.94; 1.02; 1.12; 1.25; 1.10; 0.95 | — |
| SECONDARY Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV |
54.8; 38.2; 100.0; 54.8; 44.1; 97.1 | — |
| SECONDARY Mean Level of Anti-Pneumococcal Antibody |
0.84; 1.05; 1.02; 0.98; 1.27; 1.25 | — |
| SECONDARY Percentage of Participants With Seroprotection |
71.4; 97.0; 66.7; 80.6; 66.7; 92.6 | — |
| SECONDARY Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers |
45.7; 87.5; 42.4; 80.0; 36.7; 96.2 | — |
| SECONDARY Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers |
20.0; 81.3; 15.2; 70.0; 10.0; 92.3 | — |
| SECONDARY Percentage of Participants With Seroconversion |
20.0; 81.3; 42.9; 88.9; 12.1; 70.0 | — |
| SECONDARY Strain-Specific Geometric Mean Titer Levels |
126.5; 86.0; 154.8; 390.8; 67.7; 54.0 | — |
| SECONDARY Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination |
1.31; 5.74; 1.35; 6.45; 1.25; 8.18 | — |
| SECONDARY Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions |
10.76; 7.53 | — |
| SECONDARY MRI Parameters: Number of T2 Lesions |
57.94; 45.53 | — |
| SECONDARY MRI Parameters: Categorical Number of T2 Lesions |
1; 0; 1; 1; 64; 33 | — |
| SECONDARY MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions |
2.85; 0.62 | — |
| SECONDARY MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions |
44; 31; 8; 0; 2; 1 | — |
| SECONDARY MRI Parameters: Normalized Brain Volume |
1470.51; 1456.35 | — |
| SECONDARY MRI Parameters: Volume of T2 Lesions: White Matter Volume |
808.22; 794.53 | — |
| SECONDARY MRI Parameters: Cortical Grey Matter Volume |
521.19; 519.70 | — |
| SECONDARY MRI Parameters: T1 Unenhancing Lesion Volume |
1.85; 1.31 | — |
| SECONDARY MRI Parameters: Total Number of Lesions |
25.51; 18.85 | — |
| SECONDARY Cellular Immune Response Assessed by Flow Cytometry |
97.0; 97.0; 3.0; 3.0; 100.0; 100.0 | — |
| SECONDARY Total Immunoglobulin |
13.45; 14.05; 13.45; 14.53; 13.26 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibody Formation |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation |
82.4; 50.0; 0; 0; 0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02545868) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.