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

Roche

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Biological: Influenza Vaccine; Biological: 23-PPV; Biological: 13-PCV Booster; Biological: KLH; Biological: TT Vaccine; Drug: OCR

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545868

2015-001357-32 (EudraCT Number)

BN29739

Details and patient eligibility

About

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).

Enrollment: 102 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Group A: OCR + Vaccines

Experimental group

Description:

Participants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period.

Treatment:

Drug: OCR

Biological: 13-PCV Booster

Biological: 23-PPV

Biological: Influenza Vaccine

Biological: KLH

Biological: TT Vaccine

Group B: Vaccines (Optional OCR in Extension)

Other group

Description:

Participants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.

Treatment:

Drug: OCR

Biological: 23-PPV

Biological: Influenza Vaccine

Biological: KLH

Biological: TT Vaccine