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
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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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14561 North Outer 40 Road
Chesterfield, Missouri 63017
Chesterfield, Missouri 63017
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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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