A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/17/2019 |
| Start Date: | October 27, 2015 |
| End Date: | December 13, 2022 |
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
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).
(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).
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
We found this trial at
22
sites
14561 North Outer 40 Road
Chesterfield, Missouri 63017
Chesterfield, Missouri 63017
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
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Miami, Florida 33136
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
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