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Register:	ClinicalTrials.gov
Last refreshed on:	7 February 2022
Main ID:	NCT02545868
Date of registration:	08/09/2015
Prospective Registration:	Yes
Primary sponsor:	Hoffmann-La Roche
Public title:	A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Scientific 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
Date of first enrolment:	October 27, 2015
Target sample size:	102
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02545868
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Canada	United States

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Biological: 23-PPV

Biological: Influenza Vaccine

Drug: OCR

Biological: 13-PCV Booster

Biological: TT Vaccine

Biological: KLH

Primary Outcome(s)

Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine [Time Frame: 8 weeks after TT vaccine]

Secondary Outcome(s)

Mean Levels of Anti-KLH Antibody: Ig M [Time Frame: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration]

Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G [Time Frame: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration]

Mean Level of Anti-Pneumococcal Antibody [Time Frame: Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV]

MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions [Time Frame: Baseline]

Mean Levels of Anti-Tetanus Antibody [Time Frame: Immediately prior to and at 4 and 8 weeks after TT vaccine]

MRI Parameters: Cortical Grey Matter Volume [Time Frame: Baseline]

MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions [Time Frame: Baseline]

MRI Parameters: Number of T2 Lesions [Time Frame: Baseline]

Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers [Time Frame: 4 weeks after seasonal influenza vaccine administration]

Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes [Time Frame: 4 weeks after 23-PPV]

MRI Parameters: Total Number of Lesions [Time Frame: Baseline]

Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV [Time Frame: 8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV]

Percentage of Participants With Seroprotection [Time Frame: 4 weeks after seasonal influenza vaccine administration]

Strain-Specific Geometric Mean Titer Levels [Time Frame: Baseline and Week 4]

MRI Parameters: Normalized Brain Volume [Time Frame: Baseline]

Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination [Time Frame: Immediately prior to and 4 weeks after influenza vaccine]

MRI Parameters: Categorical Number of T2 Lesions [Time Frame: Baseline]

Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers [Time Frame: 4 weeks after seasonal influenza vaccine administration]

Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation [Time Frame: During ISP (24 weeks for Group A and 12 weeks for Group B)]

Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes [Time Frame: 4 weeks after 23-PPV]

MRI Parameters: Volume of T2 Lesions: White Matter Volume [Time Frame: Baseline]

Percentage of Participants With Seroconversion [Time Frame: 4 weeks after influenza immunization]

Mean Levels of Anti-Pneumococcal Antibody [Time Frame: Immediately prior to and 4 weeks after 23-PPV]

Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers [Time Frame: 4 weeks after TT vaccine]

Total Immunoglobulin [Time Frame: Days 1, 85, and 169]

Cellular Immune Response Assessed by Flow Cytometry [Time Frame: Days 1, 15, 85, 112, 140 and 169]

MRI Parameters: T1 Unenhancing Lesion Volume [Time Frame: Baseline]

Percentage of Participants With Anti-Drug Antibody Formation [Time Frame: Up to 24 Weeks (ISP)]

Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine [Time Frame: 4 weeks after TT vaccine]

Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions [Time Frame: Baseline]

Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV [Time Frame: 4 weeks after 23-PPV]

Secondary ID(s)

2015-001357-32

BN29739

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	06/06/2018
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02545868

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