Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT04261790
• Date of registration: 06/02/2020
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis
• Scientific title: Evaluating the Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis
• Date of first enrolment: August 1, 2020
• Target sample size: 10
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04261790
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Bardia Nourbakhsh
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of relapsing remitting multiple sclerosis (RRMS) based on revised McDonald
criteria

- At least one Gd-enhancing lesions on the brain or spinal cord MRI done in the prior
three months OR at least one new T2/FLAIR lesion on the brain or spinal cord MRI done
in the prior three months (compared to a prior MRI performed within 18 months of the
most recent MRI)

- Naïve to Disease modifying therapy (DMT) or at least off these DMTs (natalizumab,
fingolimod, DMF) for three months or on an injectable DMT (interferons or glatiramer
acetate)

- Expanded Disability Status Scale (EDSS) score at the time of screening =<3

- Negative urine or serum pregnancy test must be available for premenopausal women and
for women <12 months after the onset of menopause unless these women have undergone
surgical sterilization

- Women of childbearing potential must agree to remain abstinent (refrain from
heterosexual intercourse) or use one method of contraception with a failure rate of
<1% per year or a barrier method supplemented with spermicide. Contraception must
continue for the duration of study treatment and for at least 24 weeks after the last
dose of study treatment

Exclusion Criteria:

- Contraindication to treatment with an anti- cluster of differentiation antigen 20
(CD20) antibodies, including being seropositive for HBsAg

- Active hepatitis B virus infection

- Ever received B-cell depleting antibodies (rituximab, ocrelizumab, ofatumumab),
alemtuzumab, daclizumab, mitoxantrone or hematopoietic stem-cell transplant

- Pregnant or lactating women

- Hypersensitivity to ocrelizumab

- Treatment with steroids in the past 30 days



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Ocrelizumab

Primary Outcome(s)

Change in B-cell subpopulations [Time Frame: Baseline and 18-24 months]

Change in peripheral B-cell tolerance checkpoints in people with MS before and after ocrelizumab therapy. [Time Frame: Baseline and 18-24 months]

Change in the production of anti-inflammatory cytokines produced by activated T-cells [Time Frame: Baseline and 18-24 months]

Change in the production of pro inflammatory cytokines produced by activated T-cells [Time Frame: Baseline and 18-24 months]

Change in frequency of T-cell phenotypes [Time Frame: Baseline and 18-24 months]

Secondary Outcome(s)

Change in disability as assessed by Expanded Disability Status Scale (EDSS) [Time Frame: Every 6 months, up to 30 months]

Time to return of disease activity [Time Frame: Up to 30 months]

Change in quality of life as assessed by Neuro-QoL [Time Frame: Every 6 months, up to 30 months]

Secondary ID(s)

IRB00230800

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.