A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

Autoimmune Disorder
Multiple Sclerosis (MS)

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Study Identifier NCT02545868, BN29739, 2015-001357-32

Condition Multiple Sclerosis, Relapsing-Remitting

Official Title 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

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).

Eligibility Criteria

Gender

All

Age

≥18 Years & ≤ 55 Years

Healthy Volunteers

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

VELOCE_BN29739_final-results-summary_12Aug2020_English (PDF, 0.4 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

For the latest version of this information please go to www.forpatients.roche.com