Overview

This trial is active, not recruiting.

Condition multiple sclerosis, relapsing-remitting
Treatments 23-valent ppv, booster 13-pcv, influenza vaccine, klh vaccine, ocr 300mg, tt vaccine
Phase phase 3
Sponsor Hoffmann-La Roche
Start date October 2015
End date December 2022
Trial size 102 participants
Trial identifier NCT02545868, 2015-001357-32, BN29739

Summary

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT], 23-valent pneumococcal polysaccharide vaccine [23-PPV], influenza vaccine, and keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Participants will first receive ocrelizumab (OCR) on Day 1 and Day 15, and 12 weeks post-OCR treatment will receive immunization with TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH.
23-valent ppv
The 23-valent PPV will be administered at 112 days after the first OCR administration or at Day 28 (for participants not receiving OCR).
booster 13-pcv
The booster 13-PCV will be administered on Day 140 for first subgroup of participants with OCR administration.
influenza vaccine
The influenza vaccine will be administered any time between days 84 and 140 (for second subgroup of participants with OCR administration) or any time between day 1 and 84 (for participants not receiving OCR).
klh vaccine
The KLH Vaccine will be administered at 84, 112, and 140 days after the first OCR administration or at Day 1, 28, and 56 (for participants not receiving OCR).
ocr 300mg RO4964913
OCR 300 milligram (mg) intravenous infusion administered at Day 1 and Day 15.
tt vaccine
An adsorbed TT-vaccine combined with diphtheria (tetanus-diphtheria [Td] or diphtheria and tetanus toxoid [DT]) or with diphtheria and acellular pertussis (diphtheria-tetanus-acellular pertussis [DTaP] or tetanus-diphtheria-acellular pertussis [Tdap]) will be administered at 84 days after the first OCR administration or at Day 1 (for participants not receiving OCR).
(Active Comparator)
Participants will receive immunization with TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH.
23-valent ppv
The 23-valent PPV will be administered at 112 days after the first OCR administration or at Day 28 (for participants not receiving OCR).
influenza vaccine
The influenza vaccine will be administered any time between days 84 and 140 (for second subgroup of participants with OCR administration) or any time between day 1 and 84 (for participants not receiving OCR).
klh vaccine
The KLH Vaccine will be administered at 84, 112, and 140 days after the first OCR administration or at Day 1, 28, and 56 (for participants not receiving OCR).
tt vaccine
An adsorbed TT-vaccine combined with diphtheria (tetanus-diphtheria [Td] or diphtheria and tetanus toxoid [DT]) or with diphtheria and acellular pertussis (diphtheria-tetanus-acellular pertussis [DTaP] or tetanus-diphtheria-acellular pertussis [Tdap]) will be administered at 84 days after the first OCR administration or at Day 1 (for participants not receiving OCR).

Primary Outcomes

Measure
Percentage of Participants in With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
time frame: 8 weeks after TT vaccine

Secondary Outcomes

Measure
Percentage of Participants in With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
time frame: 4 weeks after TT vaccine
Percentage of Participants in With Positive Response to 23-PPV Measured 4 Weeks After 23-PPV
time frame: 4 weeks after 23-PPV
Percentage of Participants in With KLH Immunization Measured 4 Weeks After KLH Vaccine
time frame: 4 weeks after KLH vaccine
Percentage of Participants in With Positive Response to Pneumococcal Conjugate Booster Measured 4 Weeks After the Booster 13-PCV
time frame: 4 weeks after the booster 13-PCV
Percentage of Participants in With Influenza Vaccine Response Measured 4 Weeks After the Influenza Vaccine
time frame: 4 weeks after the influenza vaccine

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Diagnosis of RMS in accordance with the revised McDonald criteria - Received at least 1 previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap) - Expanded disability status scale (EDSS) at baseline from 0 to 5.5 points, inclusive - For sexually active participants with reproductive potential, use of reliable means of contraception Exclusion Criteria: - Contraindications for or intolerance to oral or intravenous corticosteroids, including intravenous 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 (MS)

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.