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Ocrelizumab and Immune Cells in Multiple Sclerosis

This study is looking at how ocrelizumab, a common treatment for multiple sclerosis (MS), affects immune cells in lymph nodes. We know ocrelizumab clears B cells from the blood, but less is known about its effects in lymph nodes, which are important for immune system activity. This research aims to understand how well B cells are removed from lymph nodes after ocrelizumab treatment, which could impact long-term MS outcomes. You may be able to join if you are 18-65 years old, have relapsing-remitting MS (RR-MS), and are starting ocrelizumab for the first time. The study will measure changes in immune cells in lymph nodes after three months of treatment. The current status of this study is unclear.

Study design
This is a single-arm observational study involving 5 participants. It is not a blinded or randomized study.
What's involved
You would have blood and lymph node samples taken before starting ocrelizumab and again three months after treatment. You will receive two doses of ocrelizumab as part of the study.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken at 3 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06495593

Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis

Enrolling by Invitation
PHASE4Ages 18–65Interventional
University of California, San Francisco
~5 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Ocrelizumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lymphocyte analysis
Measured over 3 months

Conditions

Multiple Sclerosis, Relapsing-Remitting

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NCT06495593

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California, San Francisco

    San Francisco, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Joseph Sabatino, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Ability to provide written informed consent and be compliant with the study protocol
The treating neurologist's independent medical assessment and decision to initiate the patient on ocrelizumab treatment as most appropriate standard of care for the patient
Diagnosis of RR-MS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
Treatment-naïve (i.e. no prior disease modifying therapy)
Disease duration from the onset of MS symptoms: less than 15 years in patients with an EDSS greater than 5.0 at screening
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab

Exclusion

Diagnosis of secondary progressive MS without relapses for at least 1 year.
Diagnosis of primary progressive MS.
Prior treatment with any disease modifying therapy for MS.
Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency).
Known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis).
History of recurrent aspiration pneumonia requiring antibiotic therapy.
History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy).
Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit.
Pregnant or lactating, or intending to become pregnant during the study
Women of childbearing potential must have a negative serum or urine pregnancy test result within 14 days prior to initiation of study drug.
On systemic anti-coagulation or known blood clotting disorder.
History of or currently active primary or secondary immunodeficiency.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
History of alcohol or other drug abuse within 24 weeks prior to enrollment.
History or known presence of systemic autoimmune disorders, potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren's syndrome, Behçet's disease).
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
Significant, uncontrolled disease, as defined by AMA guidelines or similar, such as cardiovascular (including congestive heart failure - NYHA grade 3 or 4, cardiac arrhythmia), uncontrolled hypertension, pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), gastrointestinal, or any other significant disease.
Known presence or history of other neurologic disorders
Systemic corticosteroid therapy within 4 weeks prior to baseline.
Contraindications for, or intolerance to, oral or IV corticosteroids, including IV methylprednisolone, according to the country label, including hypersensitivity to any of the treatment drug constituents.
Previous treatment with cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation.
Positive serum or urine β-hCG.
Positive for hepatitis B (hepatitis B surface antigen \[HBsAg\] positive or hepatitis B core antibody \[total HBcAb\] confirmed by positive viral DNA polymerase chain reaction \[PCR\]).
AST or ALT more than 2 times the upper limit of normal.
Platelet count below lower limit of normal.
Total white blood cell count, including differential counts, below lower limit of normal.
Absolute neutrophil count below lower limit of normal.
Lymphocyte count below lower level of normal.
Levels of serum IgG 18% below the lower limit of normal (LLN) and levels of serum IgM 8% below the LLN.
Absolute CD4+ and CD8+ counts and CD4:CD8 ratio - within normal limits.

What this trial measures

  • Lymphocyte analysis3 months

    Percent reduction in B cells and T cell subsets in lymphoid tissue of MS patients following ocrelizumab treatment.